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WHO list of priority medical devices for management of cardiovascular diseases and diabetesWHO medical device technical series

WHO list of priority medical devices for management of cardiovascular diseases and diabetesWHO medical device technical series

Acknowledgemen

WHO list of priority medical devices for management of cardiovascular diseases and diabetes

(WHO medical device technical series)

ISBN 978-92-4-002797-8 (electronic version)

ISBN 978-92-4-002798-5 (print version)

© World Health Organization 2021

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iii

Contents

Acknowledgements x

Abbreviations xii

Glossary xiv

Navigation diagram xvi

Colour codes for diseases xvii

([HFXWLYH�VXPPDU\� [LYLLL

,�� %DFNJURXQG� �I.I. Sustainable development goals (SDG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �

I.III WHO Global NCD Action Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Cardiovascular diseases: global situation .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 4

Stroke: global situation .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 5

Diabetes: global situation . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 6

I.IV Availability of and access to medical devices for NCDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

,,�� 0HWKRGRORJ\� ��II.I Search and selection of clinical guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

II.II Selected clinical guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

Cardiovascular diseases (except stroke) .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ��

Stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ��

Diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ��

II.III Additional clinical guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

II.IV Relevant WHO publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

II.V Selection of the clinical interventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

III. Priority medical devices by clinical area 20III.I Priority intervention lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

III.II Introduction to listing of priority medical devices for cardiovascular diseases and diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

/HYHOV�RI�KHDOWK�FDUH .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 28

Types of medical devices, according to use.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 28

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��Clinical Assessment 29�� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�FOLQLFDO�DVVHVVPHQW�LQWHUYHQWLRQV . . . . . . . . . . . . . . . . 32

�� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�FOLQLFDO�DVVHVVPHQW�LQWHUYHQWLRQV��E\�GLVHDVH . . . . . 32

�� &DUGLRYDVFXODU�GLVHDVHV. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 32

�� 6WURNH .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 32

�� 'LDEHWHV .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 33

2. (PHUJHQF\�FDUH� �� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�HPHUJHQF\�FDUH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3. &OLQLFDO�ODERUDWRU\� �� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�FOLQLFDO�ODERUDWRU\�LQWHUYHQWLRQV . . . . . . . . . . . . . . . . .45

�� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�FOLQLFDO�ODERUDWRU\�LQWHUYHQWLRQV��E\�GLVHDVH . . . . . .47


3.2.2 Stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 47

3.2.3 Diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 48

4. 2WKHU�VSHFLDOL]HG�GLDJQRVWLFV� �� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�FOLQLFDO�DVVHVVPHQW�LQWHUYHQWLRQV�E\�GLVHDVH . . . . . 53


�� 6WURNH .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 54

�� 'LDEHWHV .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 54

v

5. Medical imaging 55�� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�PHGLFDO�LPDJLQJ�LQWHUYHQWLRQV . . . . . . . . . . . . . . . . . . 59

�� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�LPDJLQJ�LQWHUYHQWLRQV��E\�GLVHDVH . . . . . . . . . . . . . . .67


5.2.2 Stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 72

5.2.3 Diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 73

6. Surgery 75�� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�VXUJLFDO�LQWHUYHQWLRQV . . . . . . . . . . . . . . . . . . . . . . . . . . 78

�� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�VXUJLFDO�LQWHUYHQWLRQV��E\�GLVHDVH . . . . . . . . . . . . . . .��

�� &DUGLRYDVFXODU�GLVHDVHV. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ��

6.2.2 Stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 83

6.2.3 Diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 84

7. Non-surgical interventions 87�� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�QRQ�VXUJLFDO�LQWHUYHQWLRQV��E\�GLVHDVH . . . . . . . . . . .89

�� 6WURNH .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 89

�� 'LDEHWHV .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 90

8. +RVSLWDOL]DWLRQ� �� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�KRVSLWDOL]DWLRQ�LQWHUYHQWLRQV . . . . . . . . . . . . . . . . . . . .96

�� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�KRVSLWDOL]DWLRQ�LQWHUYHQWLRQV��E\�GLVHDVH . . . . . . . . .97


8.2.2 Stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 97

8.2.3 Diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 97

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9. Intensive care units 99�� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�WKH�LQWHQVLYH�FDUH�XQLW . . . . . . . . . . . . . . . . . . . . . . . . . ��

�� 6SHFLàF�SULRULW\�PHGLFDO�GHYLFHV�IRU�PRQLWRULQJ�DQG�LQWHQVLYH�FDUH�XQLW��E\�GLVHDVH . . . . ��

�� &DUGLRYDVFXODU�GLVHDVHV� .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ��

9.2.2 Stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ��

9.2.3 Diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ��

�� 5HKDELOLWDWLRQ� �� *HQHUDO�DVVLVWLYH�SURGXFWV�IRU�UHKDELOLWDWLRQ� . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

��6SHFLàF�DVVLVWLYH�SURGXFWV�IRU�UHKDELOLWDWLRQ�LQ�SHRSOH�ZLWK�FDUGLRYDVFXODU�GLVHDVH . . . ��

��6SHFLàF�DVVLVWLYH�SURGXFWV�IRU�UHKDELOLWDWLRQ�LQ�SHRSOH�ZLWK�VWURNH�GLVHDVH . . . . . . . . . . ��

��6SHFLàF�DVVLVWLYH�SURGXFWV�IRU�UHKDELOLWDWLRQ�LQ�SHRSOH�ZLWK�ORZHU�OLPE�DPSXWDWLRQ due to complication of diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

�� 3DOOLDWLYH�FDUH� �� *HQHUDO�SULRULW\�PHGLFDO�GHYLFHV�IRU�SDOOLDWLYH�FDUH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

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,9�� ,PSOHPHQWDWLRQ�VWUDWHJ\� ��IV.I Needs assessment for policy and strategy development . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

9�� &RQFOXGLQJ�UHPDUNV� ��

9,� 5HIHUHQFHV� ��

$QQH[��([SHUW�LQIRUPDWLRQ� ��

Annex 2. Search terms for clinical guidelines by � ��&RFKUDQH�1HWKHUODQG� ��

$QQH[��6KRUWHQHG�YHUVLRQ�RI�WKH�1($76�LQVWUXPHQW� ��EXLOW�RQ�WKH�IUDPHZRUN�RI�WKH�$*5((�,,�WRRO��

$QQH[��([SODQDWLRQV�FRQFHUQLQJ�PHGLFDO�GHYLFHV� ��

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)LJXUH�� Sustainable Development Goals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Figure 2. The triple billion goal of the WHO Thirteenth General Programme of Work . . . . . . . . . .2

Figure 3. The dimensions of universal health coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Figure 4. Voluntary global targets for prevention and control of NCDs to be attained by 2025 . . . . .3

Figure 5. Age-standardized cardiovascular disease mortality rates (per 100 000 population) for both sexes by country, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Figure 6. Age-standardized stroke mortality rates (per 100 000 population) for both sexes by country, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Figure 7. Age-adjusted trends in prevalence of diabetes, 1980–2014, by World Bank country income group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Figure 8. Age-standardized Diabetes mellitus mortality rates (per 100 000 population) for both sexes by country, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Figure 9. Percentage of countries with availability of essential technologies for early detection, diagnosis and monitoring of NCDs in the primary care facilities of the public and private health sectors, by WHO region and World Bank income group . . . . . . . . . . . . .9

)LJXUH�� Percentage of countries with procedures generally available for treating NCDs in the public health care system, by World Bank income group . . . . . . . . . . . . . . . . . . . . .9

)LJXUH�� WHO sources for cardiovascular disease management . . . . . . . . . . . . . . . . . . . . . .10

)LJXUH�� Methodology: from disease identification to dissemination of information . . . . . . . . . . . 12

)LJXUH�� General needs assessment process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131

Tables7DEOH�� List of selected clinical guidelines for cardiovascular diseases .. .. .. .. .. .. .. .. .. .. .. 15

Table 2. List of selected clinical guidelines for stroke. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 16

Table 3. List of selected clinical guidelines for diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 17

Table 4. List of additional clinical guidelines .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 18

Table 5. Relevant WHO publications .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 19

Table 6. General priority clinical interventions. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 20

Table 7. Priority clinical interventions for cardiovascular diseases except stroke . .. .. .. .. .. .. .. .. 22

Table 8. Priority clinical interventions for stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 24

Table 9. Priority clinical interventions for diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 26

7DEOH�� List of clinical assessment interventions. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 31

7DEOH�� List of general priority medical devices for clinical assessment interventions .. .. .. .. .. .. .. 32

7DEOH�� List of specific priority medical devices for clinical assessment interventions for cardiovascular diseases .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 32

7DEOH�� List of specific priority medical devices for clinical assessment interventions for stroke. .. .. .. 32

7DEOH�� List of specific priority medical devices for clinical assessment interventions for diabetes .. .. .. 33

7DEOH�� List of general priority medical devices for emergency care . .. .. .. .. .. .. .. .. .. .. .. 38

7DEOH�� List of general priority medical devices for medicalized ground transportation .. .. .. .. .. .. 40

7DEOH�� List of clinical laboratory interventions .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 44

7DEOH�� List of general priority medical devices for clinical laboratory interventions .. .. .. .. .. .. .. 45

7DEOH�� List of general priority medical devices for washing and sterilizing . .. .. .. .. .. .. .. .. .. 46

Table 20. List of specific priority medical devices for clinical laboratory interventions for cardiovascular diseases .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 47

7DEOH�� List of specific priority medical devices for clinical laboratory interventions for stroke .. .. .. .. 47

Table 22. List of specific priority medical devices for clinical laboratory interventions for diabetes .. .. .. 48

Table 23. List of specialized diagnostic interventions .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 53

Table 24. List of specific priority medical devices for specialized diagnostics interventions for cardiovascular diseases .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 53

Table 25. List of specific priority medical devices for specialized diagnostics interventions for stroke .. .. 54

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Table 26. List of specific priority medical devices for specialized diagnostics interventions for diabetes .. 54

Table 27. List of medical imaging procedures.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 58

Table 28. List of general medical devices for ultrasound medical imaging .. .. .. .. .. .. .. .. .. .. 59

Table 29. List of general medical devices for X-ray radiography medical imaging (levels of care 2 and 3) .. 60

Table 30. Medical devices for general X-ray radiography medical imaging (only for interventions at level of care 2 and 3) .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 60

7DEOH�� List of general medical devices for angioscopy and angiography .. .. .. .. .. .. .. .. .. .. 61

Table 32. List of general medical devices for CT .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 62

Table 33. List of general medical devices for SPECT nuclear medical imaging .. .. .. .. .. .. .. .. .. 63

Table 34. List of general medical devices for general PET nuclear medical imaging .. .. .. .. .. .. .. 65

Table 35. List of general medical devices for MRI medical imaging .. .. .. .. .. .. .. .. .. .. .. .. 66

Table 36. List of specific priority medical devices for imaging interventions for cardiovascular diseases .. 67

Table 37. List of specific priority medical devices for imaging interventions for stroke.. .. .. .. .. .. .. 72

Table 38. List of specific priority medical devices for imaging interventions for diabetes .. .. .. .. .. .. 73

Table 39. List of surgical interventions .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 77

Table 40. List of general priority medical devices for surgical interventions .. .. .. .. .. .. .. .. .. .. 78

7DEOH�� List of specific priority medical devices for surgical interventions for cardiovascular diseases.. .. 82

Table 42. List of specific priority medical devices for surgical interventions for stroke.. .. .. .. .. .. .. 83

Table 43. List of specific priority medical devices for surgical interventions for diabetes .. .. .. .. .. .. 84

Table 44. List of priority non-surgical interventions .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 89

Table 45. List of specific priority medical devices for non-surgical interventions for stroke .. .. .. .. .. 89

Table 46. List of specific priority medical devices for non-surgical interventions for diabetes. .. .. .. .. 90

Table 47. List of hospitalization interventions .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 95

Table 48. List of general priority medical devices for hospitalization interventions .. .. .. .. .. .. .. .. 96

Table 49. List of specific priority medical devices for hospitalization interventions for cardiovascular diseases .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 97

Table 50. List of specific priority medical devices for hospitalization interventions for stroke . .. .. .. .. 97

7DEOH�� List of specific priority medical devices for hospitalization interventions for diabetes .. .. .. .. 97

Table 52. List of intensive care unit interventions.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 102

Table 53. List of general priority medical devices for intensive care unit interventions .. .. .. .. .. .. .. 103

Table 54. List of specific priority medical devices for intensive care unit interventions for cardiovascular diseases .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 104

Table 55. List of specific priority medical devices for intensive care unit interventions for stroke . .. .. .. 105

Table 56. List of specific priority medical devices for intensive care unit interventions for diabetes .. .. .. 105

Table 57. List of rehabilitation interventions .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 111

Table 58. Assistive products, equipment and consumables required for general rehabilitation .. .. .. .. 113

Table 59. Assistive products, equipment and consumables required for rehabilitation in people with heart disease (ischemic heart disease) .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 114

Table 60. Assistive products, equipment and consumables required for rehabilitation in people with stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 115

7DEOH�� Assistive devices, equipment and consumables for rehabilitation in people with lower limb amputation due to diabetes.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 121

Table 62. List of general priority medical devices for palliative care interventions .. .. .. .. .. .. .. .. 128

Table 63. List of general priority medical and assistive devices for pain management, by domain .. .. .. 129

7DEOH�$�� Experts on cardiovascular diseases and related medical devices .. .. .. .. .. .. .. .. .. .. 138

7DEOH�$�� Experts on stroke and related medical devices .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 138

7DEOH�$�� Experts on diabetes and related medical devices .. .. .. .. .. .. .. .. .. .. .. .. .. .. 139

7DEOH�$��Search criteria for guidelines on cardiovascular diseases .. .. .. .. .. .. .. .. .. .. .. .. 140

Table A2.2 Search criteria for guidelines on stroke .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 140

Table A2.3 Search criteria for guidelines on diabetes .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 141

7DEOH�$��Description of select medical devices . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 143

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etes This publication was developed in response to the need for a reference list of priority medical devices required

for management of noncommunicable diseases (NCDs), focusing on cardiovascular diseases and diabetes,

especially for low- and middle-income countries to support universal health coverage actions. The current

list complements the WHO List of priority medical devices for COVID-19 published in 2020, the WHO list of

priority medical devices for cancer management published in 2017 and the Interagency list of medical devices

for essential interventions for reproductive, maternal, newborn and child health published in 2015.

The project was developed under the overall coordination of Adriana Velazquez Berumen, Team Lead, Medical

Devices and In Vitro Diagnostics, with the guidance from Clive Ondari, Director of the Health Product Policy

and Standards Department and under the leadership of Mariangela Simao, Assistant Director General of the

Access to Medicines and Health Products Division, WHO. Strategic and technical guidance was received from

Cherian Varghese, Coordinator, and Taskeen Khan and Gojka Roglic from the Noncommunicable Diseases

Management Department, and Walter Johnson from the Health Service Delivery Department, WHO. Technical

input for emergency chapter was received from Pryanka Relan and Teri Reynolds; for Rehabilitation chapter

and assistive products from Alarcos Cieza, Alexandra Rauch, Emma Tebbutt, Giulia Oggero and Louise Puli;

and for clinical Laboratory by Ana Aceves and Nikhil Moorchung†, WHO.

Technical support was provided by WHO interns working in the medical devices area: Alitzel Díaz (July to

December 2017), Enrico Giuseppe Ferro (January to April 2018), Mar Elena (June to August 2018), Karen Kulp

(September to December 2018), Joshua Daniel (December 2018 to May 2019), Magdalena Plotczyk (May to

September 2019), Valeria Montant (September to December 2019), who integrated the whole document, and

Daniela Rodriguez (2021) who supported the final review for publication clearance.

WHO acknowledges all the participants of the consultation meeting, teleconferences and international experts

that reviewed this document and provided expert advice in the development of this publication, as follows:

Consultants: Alfonso Rosales, (cardiovascular diseases, 2018), Antonio Migliori (all chapters, 2018 and 2020),

Lotty Hooft (clinical guideline selection, 2018).

Disease experts: Pablo Aschner (diabetes), Ivana Blazic (medical imaging), Anirudh V. Kulkarni (stroke),

Pranay Pawar (stroke) and Hiroshi Ogawa (oral health).

11–12 July 2019: expert participants in consultation meeting in Geneva, Switzerland

Invited participants: Shrish Naresh Acharya (Fiji), Donald DiPette (United States of America), Emma English

(United Kingdom), Keiko Fukuta (Japan), Babacar Gueye (Senegal), Santiago Hasdeu (Argentina), Garry

John (United Kingdom), Ganesan Karthikeyan (India), Alexander Kostyuk (Kazakhstan), Belma Malanda

(Democratic Republic of the Congo/Belgium), Patrik Michel (Switzerland), Ambady Ramachandran

(India), Jitendra Sharma (India), Pascal Soroheye (Benin), Alessandro Stievano (Italy), Gabriele Thumann

(Switzerland), Isabel Watanabe Ortega (Mexico) and, Dinsie Williams (Sierra Leone/Canada).

WHO participants: Gilles Forte, Walter Johnson, Taskeen Khan, Silvio Mariotti, Ashley Moore, Mercedes Perez,

Magdalena Plotczyk, Sameer Pujari, Gojka Roglic, Haitham Shoman, Adriana Velazquez Berumen, Cherian

Varghese and Edward Whittaker. WHO Iraq country office: Kamel Abdul Rahim.

WHO consultants: Lotty Hooft, Antonio Migliore and Alexandra Rauch.

The financial support for the technical advisers meeting was provided by the Centers for Disease Control and

Prevention of the United States of America as support to the WHO Cardiovascular Programme.

August to December 2019: experts review

Expert reviewers: Alan Wainwright (Institute of Biomedical Science), Laura Patricia López Meneses and

Jorge Gabriel Garcia Gutierrez (Mexico), Karin Imoberdorf, Norwina Mohd Nawawi and Zhipeng Lu (Public

Health Group of the International Union of Architects), Marie Nora Roald (International Federation of

Biomedical Laboratory Science), Stewart Whitley (International Society of Radiographers and Radiological

Technologists), Sverre Sandberg (European Federation of Clinical Chemistry and Laboratory Medicine), Dinsie

Williams (International Federation for Medical and Biological Engineering collaborating member), Maurice

Page (AFIB, France), Cesar Burgi Vieira and Eunice Lourenço (Portugal).

Acknowledgements

https://www.who.int/publications/i/item/WHO-2019-nCoV-MedDev-TS-O2T.V2

https://www.who.int/publications/i/item/9789241565462




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International Council of Nurses, World Stroke Organization, International Federation of Biomedical Laboratory

Science, Public Health Group of the International Union of Architects, and International Federation for Medical

and Biological Engineering.

Photo credits:

Cover: WHO/Andrew Esiebo, WHO/Quinn Mattingly, WHO/Adriana Velazquez Berumen

Page 19: WHO/Andrew Esiebo

Page 25: WHO/Francisco Guerrero

Page 29: WHO/Jane Gershen

Page 35: WHO/Jane Gershen

Page 41: WHO /Quinn Mattingly

Page 51: WHO/Tania Habjouqa

Page 75: WHO/Yoshi Shimizu

Page 87: WHO/Tania Habjouqa

Page 93: WHO/Quinn Mattingly

Page 107: WHO/NOOR/Sebastian Liste

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dise

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and

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etes ABPM ambulatory blood pressure monitoring

ACR albumin–creatinine ratio

AED automated external defibrillator

APTT activated partial thromboplastin time

BMI body mass index

BNP B-type natriuretic peptide

BPAP bi-level positive airway pressure

cath lab catheterization laboratory

CCU coronary care unit

CPAP continuous positive airway pressure

CPG Clinical Practice Guideline

CRPS chronic regional pain syndrome

CRT cardiac resynchronization therapy

CSF cerebrospinal fluid

CT computed tomography

DICOM Digital Imaging and Communications in Medicine

DSA digital subtraction angiography

EEG electroencephalograph

EMG electromyography

ESR erythrocyte sedimentation rate

EVD extraventricular drain

GDG Guideline Development Group

GFR glomerular filtration rate

Hb haemoglobin

HbA1c haemoglobin A1c

Hct haematocrit

ICD-11 International Classification of Diseases, 11th Revision

ICHI International Classification of Health Interventions

ICT information and communication technology

ICU intensive care unit

IT information technology

IV intravenous

MRI magnetic resonance imaging

NCD noncommunicable disease

Abbreviations

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Ab

bre

via

tion

s

NEATS National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards

NIV non-invasive ventilation

OCT optical coherence tomography

PACS picture archiving and communication system

PEEP positive end expiratory pressure

PEG percutaneous endoscopic gastrostomy

PEN package of essential noncommunicable disease interventions for primary health care in low-resource settings

PET positron emission tomography

PT/INR prothrombin time and international normalized ratio

PTT partial thromboplastin time

SDG Sustainable Development Goal

SPECT single photon emission computed tomography

T3 triiodothyronine

T4 thyroxine

TRIP Turning Research into Practice

TRUST Transparency and Rigour Using Standards of Trustworthiness

TSH thyroid-stimulating hormone

UV ultraviolet

VEGF vascular endothelial growth factor

WHO World Health Organization

xiv

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dise

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etes The definitions have been standardized across WHO publications, including the WHO list of priority

medical devices for cancer management.

Accessibility: People’s ability to obtain and appropriately use good-quality health technologies when

they are needed.

Adverse event: Any untoward medical occurrence in a subject, whether device related or not.

Affordability: In the context of this report, the extent to which the intended recipients of a service can

pay for it, be it a public, governmental or private service.

Appropriate(ness): Medical methods, procedures, techniques and equipment that are scientifically

valid, adapted to local needs, and acceptable to both patient and health care personnel, and that can

be utilized and maintained with resources the community or country can afford.

Assistive products: Any external product (including devices, equipment, instruments or software),

specially produced or generally available, the primary purpose of which is to maintain or improve an

individual’s functioning and independence, and thereby promote their well-being. Assistive products

are also used to prevent impairments and secondary health conditions.

Capital medical devices: Medical equipment and devices that providers of health services have

acquired during the accounting period and that are used repeatedly or for more than one year in the

provision of health services. 1

Clinical guideline: Systematically developed statements to assist practitioner and patient decisions

about appropriate health care for specific clinical circumstances.

Consumables/single-use medical devices: Supplies required for the use of the equipment but allowing

only limited, or no, reuse.

e-health: The use of information and communication technologies for health.

General medical devices: Indispensable medical devices for basic use of the clinical unit to perform a

majority of interventions for a wide scope of diseases. Range of specification may vary depending of

the level of healh.

Health care: Any type of service provided by professionals or paraprofessionals with an impact on

health status

Medical device: An article, instrument, apparatus or machine that is used in the prevention, diagnosis

or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the

structure or function of the body for some health purpose. Typically, the purpose of a medical device

is not achieved by pharmacological, immunological or metabolic means. Medical devices include

medical equipment, surgical instruments, implantable medical devices, in vitro diagnostics, solutions

and disinfection substances, clothing, accessories and single-use devices.

Medical equipment: Medical devices requiring calibration, maintenance, repair, user training and

decommissioning – activities usually managed by clinical engineers. Medical equipment is used

for the specific purposes of diagnosis and treatment of disease or interventions provided during

rehabilitation following disease or injury; it can be used either alone or in combination with any

accessory, consumable, or other piece of medical equipment. Medical equipment excludes implantable,

disposable or single-use medical devices.

1 A system of health accounts: 2011 edition. OECD, European Union and World Health Organization; 2011 (https://www.who.int/health-accounts/methodology/sha2011.pdf).

Glossary

xv

Glo

ssary

Medical furniture: Furniture used in medical settings (hospitals, or any other health care units) for medical

purposes (for example, cabinets to store medical equipment).

Personal protective equipment and clothing: Personal protective equipment, commonly referred to as PPE,

is equipment worn by health care workers to minimize exposure to a variety of hazards. Examples of PPE

include such items as gloves, foot and eye protection, protective hearing devices (earplugs, muffs) hard

hats, respirators, lead aprons and full body suits. This category includes the equipment used to cover and

protect the patient, such as gowns and face masks.

Priority assistive products: Those assistive products that are highly needed, an absolute necessity to

maintain or improve an individual’s functioning and which need to be available at a price the community/

state can afford.

Priority medical devices: Those medical devices that are indispensable to perform a health intervention,

of an evidence based clinical practice guideline of a priority diseases or health condition. These medical

devices need to be of good quality, effective, appropriate, affordable, accessible and acceptable to the

final user. They need to be available to respond to the priority health needs of the setting and should be

used safely by the health care worker or final user. The priority medical devices, especially the ones that

are most costly and complex, require specific infrastructure and trained human resources, and need an

assessment process to evaluate if these can be placed for public procurement or considered in the package

of interventions as a reimbursable procedure/product. These assessments consider not only the safety

and efficacy of the technology, but also feasibility, cost effectiveness, ethical, organizational and human

resources requirements. Those devices have specific intended use from prevention and protection to

diagnosis, monitoring, treatment or palliation, to inform the development of national priority lists.

Quality assurance equipment: Equipment clinically relevant to carry out a calibration process needs to

meet international standards considering calibration factors. Also called auxiliary dosimetry equipment, for

example ionization chambers, phantoms and chamber sleeves.

Specific medical devices: Medical devices for diagnosis or treatment of a specific type of condition or

disease and used for specific clinical intervention.

xvi

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etes In this publication, the priority medical devices that are discussed, selected and presented are organized

by clinical unit in a health service provision. The navigation diagram in Figure 1 represents the range of

health-related interventions, from pre-hospital activities to highly specialized tertiary hospital-based care.

The selected clinical interventions, and thus the medical devices, are required throughout the continuum of

care, from prevention, diagnosis and monitoring, treatment, intensive care, rehabilitation, to palliative care,

in any of the following clinical areas: clinical assessment, emergency care, clinical laboratory, surgery, non-

surgical interventions, intensive care, hospitalization, rehabilitation and palliative care. It should be noted

that the navigation diagram represents the units required for diagnosis and treatment of cardiovascular

diseases and diabetes.

Click on the diagram to navigate to any section.

PR

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S

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Key: * Including cardiovascular, neurological,

ophthalmic and nefrology.CL community level; health postDH district/general hospital; interventions can also

be offered in a first referral outpatient clinic

HC health centre/outpatient clinicSH specialized/regional/national hospital;

specialized care outpatient unit

Advanced emergency care

Clinical laboratory

Clinical assessment

Medical imagingDiagnostic Interventional

Specialized diagnostics

Digital health support interventions

Diagnosis/monitoring

Point of care

Specialized surgery*

General surgery

Non- surgical interventions

Pre-hospital emergency care

Intensive care

Hospitaliza-tion

Rehabilitation

Basic emergency care

Palliative care

Post surgery/intensive careTreatment End-of-life

care

Rehabilitation

Navigation diagram

xvii

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Since this publication covers different diseases, throughout the listing of medical devices, the intervention are

general, used for various diseases or health conditions, or specific for either cardiovascular diseases (except

stroke), stroke or diabetes. The tables will obey the following code of colour to facilitate the identification of

the disease they are aimed for:

General

Cardiovascular except stroke

Stroke

Diabetes

Colour codes for diseases

xviii

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etes Medical devices are required to provide health care and to improve the health of individuals and populations.

They are indispensable for prevention, diagnosis, treatment, rehabilitation, palliative care, and are used along

the continuum of health service provision from primary care to specialized hospitals. Of the thousands types

of medical devices currently available,2 the current challenge for health care providers and government

institutions is to select which specific technologies are needed for the management of health conditons or

high-burden diseases, at a given health care level and in a given context, to include in their national list.

The increase in the prevalence of noncommunicable diseases (NCDs) demanded that the World Health

Organization (WHO) identify appropriate and relevant medical devices and develop a prioritized list that

can serve as a reference for Member States to develop or update their national lists of medical devices for

public procurement, reimbursement, and tracking availability. The final goal of this publication is to guide

on the selection, in order to increase access to medical devices required to prevent, diagnose and treat

cardiovascular diseases and diabetes, especially in low and middle resource settings.

Objectives of this publication were to:

• determine and select the medical devices required for priority interventions to manage cardiovascular

diseases and diabetes aligned with WHO guidance, policies and evidence-based guidelines;

• expand the WHO Priority Medical Devices lists, these now include reproductive, maternal, new born

and child health, the ones for cancer management and the most recent ones for COVID-19, to those for

cardiovascular diseases and diabetes, which will become global guidances that Member States can use

as a reference to define their national medical devices lists;

• provide guidance to countries, national and regional health departments, and health facilities to

prioritize medical devices for procurement or reimbursement to manage NCDs in their settings.

For an overview of country implementation, the next steps are suggested:

• define a system to undertake a medical device needs assessment in each target country, in conjunction

with other United Nations and international organizations, with the aim of identifying the medical

equipment required to address the national disease burden for NCD care at country level;

• organize local workshops on health technology regulatory frameworks, assessments and management

for relevant national health officials, academics and other stakeholders in target countries, using existing

WHO tools and resources to strengthen regional or national health deliver capacity.

The first section of this publication introduces the Sustainable Development Goals (SDGs), universal health

coverage, and the WHO Global Action Plan for the Prevention and Control of NCDs 2013–2020, and presents

global statistics for non communicable diseases.

The second section presents the methodology used to select priority medical devices for the clinical

interventions required to diagnose, treat and monitor patients living with those conditions.

The third section lists priority medical devices required to manage all three conditions in different units of

health care services, as follows:

• clinical assessment

• emergency care

• clinical laboratory

• specialized diagnostics

• medical imaging

• surgery

• non-surgical interventions

• hospitalization

• intensive care unit (ICU)

• rehabilitation

• palliative or end-of-life care

2 Standardization of medical devices nomenclature: http://apps.who.int/gb/ebwha/pdf_files/EB145/B145_3-en.pdf

Executive summary

http://apps.who.int/gb/ebwha/pdf_files/EB145/B145_3-en.pdf?ua=1.

xix

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The lists include technologies required to support general clinical interventions (some of which were presented

in previous WHO documents), as well as specific priority medical devices to manage cardiovascular diseases

and diabetes. To facilitate budget planning and procurement, medical devices are classified either as capital

equipment or as accessories, consumables, software or single-use devices. In addition, each section provides

information on the clinical unit.

The fourth section proposes the strategies required in settings where the presented lists of priority medical

devices are to be implemented. The activities include performing a needs assessment, cross-referencing and

adjusting medical device lists according to country priorities, infrastructure, specialized human resources

available, and budget. It is important to note that high-impact technologies (for example, those with high cost

or requiring radical organizational changes) for specialized hospitals may require a comprehensive health

technology assessment considering contextual variables and local settings.

The annexes include the expert information, search terms and the National Guideline Clearinghouse (NGC)

Extent of Adherence to Trustworthy Standards (NEATS) instrument for selection of clinical guidelines, as well

as the list of clinical interventions selected in this study.

This publication is intended for ministries of health, public health planners, health technology managers,

disease managers, researchers, policy-makers, funding and procurement agencies, and support and advocacy

groups for patients suffering from cardiovascular diseases and diabetes. It serves to inform policy-makers

and technical decision-makers on the selection of medical devices required for the package of benefits and

interventions for a target population in the context of universal health coverage, to be considered in their

national medical devices list.

Special acknowledgments go to all experts involved in the development of this document, who collaborated

with the main goal of helping Member States, NGOs, academia, and the private sector, to improve management

of patients worldwide, and especially in low-resource settings.

1

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I.I. Sustainable development goals (SDG)In 2015, all States Members of the United Nations adopted the 2030 Agenda for Sustainable Development.

The Agenda is based on 17 Sustainable Development Goals (SDGs), which are an urgent call for action by

all countries, at all stages of development, to cooperate in a global partnership for sustainable development

(Figure 1).3 The SDGs recognize that ending poverty must go hand in hand with strategies that build

economic growth and address a range of social needs, including education, health, social protection and job

opportunities, while tackling climate change and environmental protection.

Figure 1. Sustainable Development Goals

Health is directly connected to many of the SDGs, most importantly SDG 3: Ensure healthy lives and promote

well-being for all at all ages. That is why the World Health Organization (WHO) has made the SDGs the focus

of its new and future projects to support efforts towards universal health coverage, including the Global

Action Plan for Healthy Lives and Well-being for All (SDG 3 Global Action Plan).

I.II Universal health coverageUniversal health coverage means that all people and communities can use the promotive, preventive, curative,

rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring

that the use of these services does not expose the user to financial hardship. In 2019, WHO set out its

new five-year strategic plan in the Thirteenth General Programme of Work 2019–2023, which includes the

“triple billion” goal – ensuring that 1 billion more people benefit from access to universal health coverage,

1 billion more people are better protected from health emergencies, and 1 billion more people enjoy better

health and well-being (Figure 2) (1, 2). Reaching this goal will require addressing the threats to health from

a variety of angles.

I. Background

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Importantly, universal health coverage, the first of the three goals, depends in large part on access to essential

medicines, vaccines and health products, including medical devices, as well as the quality of the health

workforce, health facilities and information (Figure 3) (3).

Figure 3. The dimensions of universal health coverage

This publication is the outcome of a project developed by WHO in response to the need for a model reference

list of basic and priority medical devices required for noncommunicable diseases (NCDs) based on the Global

Status Report on noncommunicable diseases 2014 (4), with the goal of increasing access to these medical

devices, especially in low- and middle-income countries to complement the Priority Medical devices for

Cancer management (2017).

Extend to non-covered

Reduce cost sharing

and fees Include other services

Current pooled funds

Direct costs: proportion of the costs covered

Population: who is covered?

Services:

which services

are covered?

3

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I.III WHO Global NCD Action PlanNCDs – including cardiovascular diseases, cancers, chronic respiratory diseases and diabetes – are the world’s

biggest killers. More than 40 million people die annually from NCDs (74% of global deaths), including more

than 15 million people who die too young between the ages of 30 and 70. Low- and middle-income countries

already bear 85% of the burden of these premature deaths. (5).

Most of these premature deaths from NCDs are largely preventable by enabling health systems to respond

more effectively and equitably to the health care needs of people with NCDs and influencing public policies in

sectors outside health that tackle shared risk factors, including tobacco use, unhealthy diet, physical inactivity

and the harmful use of alcohol.

To strengthen national efforts to address the burden of NCDs, the World Health Assembly endorsed the WHO

Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013–2020 in May 2013 (5). The Global NCD Action Plan provides Member States, international partners and WHO with a roadmap and

menu of policy options that, when implemented collectively between 2013 and 2020, would contribute to

progress on nine global NCD targets to be attained in 2025. One of these nine targets specifically address the

issue of access to medical technologies and aims at an increase up to “an 80% availability of the affordable

basic technologies and essential medicines, including generics, required to treat major noncommunicable

diseases in both public and private facilities” (Figure 4) (6).

Figure 4. Voluntary global targets for prevention and control of NCDs to be attained by 2025

16 BACKGROUND

public health challenge of diabetes and to generate momentum for national, regional and global action. Part 1 presents an overview of the global prevalence of diabetes, the burden of mortality related to blood glucose, and what is known about the extent of diabetes-related complications. Part 2 reviews evidence for action to prevent type 2 diabetes through population-wide and targeted interventions. Part 3 discusses diagnosis and early detection

of diabetes, along with actions required to improve outcomes for those living with it. Part 4 gives the current status of national responses to diabetes and provides data on efforts to monitor, prevent and manage it (diabetes country profiles are available at www.who.int/diabetes/global-report). The final section presents conclusions and recommendations for realizing the global commitments made to prevent diabetes and reduce its health impact.

BOX 1. VOLUNTARY GLOBAL TARGETS FOR PREVENTION AND CONTROL OF NONCOMMUNICABLE DISEASES TO BE ATTAINED BY 2025

Source: (34).

4

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Cardiovascular diseases are a group of diseases of the heart muscle, valves, conduction system and blood

vessels, which manifest primarily as heart attacks and strokes (about 80% of all deaths form cardiovascular

disease) (7). Of less prevalence but major importance are heart failure, valvular disease and arrhythmia.

Cardiovascular diseases are a major cause of disability and premature death throughout the world, taking

the lives of 17.9 million people in 2019, of which 81% occur in developing countries and over one third are

premature deaths (Figure 5) (8). The underlying pathology is atherosclerosis, a build-up of fatty deposits

on the inner walls of the blood vessels, which reduces blood flow to the heart muscle through an acutely

obstructive process or over many years. It is usually advanced by the time symptoms occur. Acute coronary

events (heart attacks) and cerebrovascular events (strokes) frequently occur suddenly and are often fatal

before medical care can be given (9).

Figure 5. Age-standardized cardiovascular disease mortality rates (per 100 000 population) for both sexes by country, 2019

Source: Global Health Estimates (GHE) (17).

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Stroke: global situation

Stroke was the second leading cause of death in 2019, with 6.2 million lives lost globally. It has occupied a

high spot on the list of the leading causes of death worldwide for the past 20 years (10). Stroke also causes

significant morbidity and is the second-leading cause of disability-adjusted life-years (11). Early recognition

of the symptoms of a stroke and access to medical care are crucial to saving patients’ lives and improving

outcomes (12). Rehabilitation is often necessary to address residual functional deficits following a stroke to

achieve and maintain optimal levels of functioning.

A stroke occurs when blood flow to the brain is interrupted. There are two types of stroke. Ischaemic strokes

are caused by a blockage in an artery, usually created by a clot; haemorrhagic strokes occur when a blood

vessel bursts. The symptoms of stroke vary depending on the area of the brain that is affected. Often the

symptoms occur on one side of the body and result in weakness and loss of sensation. Other signs may

include severe headache, confusion or difficulty speaking. The symptoms can range from mild to severe

or even result in sudden death (13). Diagnostic testing to distinguish the type of stroke that the patient is

experiencing is a key factor in saving lives and improving post-stroke quality of life.

Strokes are on the rise in low- and middle-income countries, with rates more than doubling over the past 40

years (14). Mortality attributed to stroke by country is depicted in Figure 6. Differences between sexes in stroke

incidence, prevalence, mortality, and outcomes have been documented worldwide. Although men are at higher

risk of stroke for most age groups, women older than 85 are at higher risk. In addition, women have worse post-

stroke recovery than men. (15). Effective stroke prevention involves management of hypertension, diabetes and

high cholesterol in addition to lifestyle changes such as smoking cessation, increased exercise and a healthy diet.

Treatment and rehabilitation relies on the availability of medical devices used to diagnose the condition promptly,

technologies to aid health care providers in the delivery of care, and staff that are trained to use these tools

appropriately. Low- and middle-income countries are disadvantaged in their level of access to such resources (16).

Figure 6. Age-standardized stroke mortality rates (per 100 000 population) for both sexes by country, 2019



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etes Diabetes: global situation

Approximately 422 million adults had diabetese in 2014. (18). A study in 2013 suggests that almost half of

all diabetes cases in adults were undiagnosed. (19). Diabetes has detrimental effects throughout the body

and the impacts accumulate over time (20). If diabetes is not effectively managed, debilitating and life-

threatening complications can arise.

Diabetes was the ninth most common cause of death worldwide in 2019 (10). Of the 1.5 million deaths due

to diabetes, 48% occur before the age of 70 years (20). Low- and middle-income countries experience

higher premature mortality from diabetes due to reduced access to the resources necessary to successfully

identify and manage the disease (21). Unfortunately, these are the same areas where diabetes rates are

increasing the most rapidly (Figure 7). The global distribution of Diabetes mellitus mortality is depicted in

Figure 8. The prevalence of diabetes has nearly quadrupled over the past three decades. This is partly due

to an ageing population (as age is a risk factor), but in large part also due to the increasing prevalence of

preventable risk factors, such as obesity and physical inactivity. In 2015, low- and middle-income countries

lost an estimated US$ 507 billion to diabetes costs (20), and had significantly higher mortality rates than

high-income countries (22).

Figure 7. Age-adjusted trends in prevalence of diabetes, 1980–2014, by World Bank country income group

Source: WHO Global report on diabetes (20).

Diabetes impairs the body’s ability to convert food or caloric beverages into energy. It is a complex metabolic

disorder characterized by chronic hyperglycaemia, with disturbances of carbohydrate, fat and protein

metabolism. Poorly managed diabetes increases the risk of cardiovascular disease, infection, kidney failure,

vision loss, depression and dementia. A combination of commonly occurring peripheral nerve damage and

arterial disease is the pathway to non-healing foot ulcers, often leading to infection and limb amputation (23).

Two common types of diabetes are type 1 diabetes, which requires insulin for survival, and type 2 diabetes,

which develops over time as the resistance to insulin within the cells increases and insulin production decreases

(20). There is no preventive intervention for type 1 diabetes, but the onset and progression of type 2 diabetes

to complications can be slowed or even halted through lifestyle modification and adherence to proper health

care interventions. Approximately 95% of diabetes cases are type 2 diabetes (23). Rehabilitation becomes

important to those who experience complications related to diabetes. In people following amputation,

rehabilitation helps to achieve the best possible level of functioning and independence.

26 GL OBAL BURDEN OF DIABE T ES

1. Unless otherwise noted, prevalence estimates reported in this section are age-standardized.

In the past 3 decades the prevalence 1 (age-standardized) of diabetes has risen substantially in countries at all income levels, mirroring the global increase in the number of people who are overweight or obese. The global prevalence of diabetes has grown from 4.7% in 1980 to 8.5% in 2014, during which time prevalence has increased or at best remained unchanged in every country (4). Over the past decade, diabetes prevalence has risen faster in low- and middle-income countries than in high-income countries (see Figure 4a). The WHO Eastern Mediterranean Region has experienced the greatest rise in diabetes prevalence, and is now the WHO region with the highest prevalence (13.7%) (see Figure 4b).

TYPE 1 DIABETES

Distinguishing between type 1 and type 2 diabetes is not always easy as it often requires relatively sophisticated laboratory tests for pancreas function. Distinct global estimates of diabetes prevalence for type 1 and type 2 therefore do not exist.

Much of our knowledge of the incidence of type 1 diabetes relates to children and has been generated by collaborative initiatives to develop population-based, standardized registries of new cases worldwide, such as the WHO DIAMOND Project (5). Globally, these registries recorded large differences in the incidence and prevalence of type 1 diabetes, ranging from over 60 to under 0.5 cases annually per 100 000 children aged under 15 years; differences in case ascertainment

FIGURE 4A. TRENDS IN PREVALENCE OF DIABETES, 1980–2014, BY COUNTRY INCOME GROUP

10%

8%

6%

4%

2%

0%

1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014

Prev

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Low-income Lower middle-income

High-incomeUpper middle-income

World

Diabetes prevalence has doubled since 1980

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Lack of resources is a common barrier to early diagnosis and effective management of diabetes. No data

exist to reflect the extent of the problem across all levels of health care delivery. However, in low-income

countries, less than half of all primary health care facilities have basic supplies for glucose measurement.

Primary health care facilities in low-, middle-, and upper middle-income countries struggle to screen for

serious complications that are common in diabetes, because less than 50% have the necessary equipment.

While is it likely that tests and devices for monitoring diabetes and diagnosing and treating its complications

are available in a few specialized institutions, it is important to make some of them more widely available.

Countries hoping to reduce health care expenditure will need to invest both in procuring evidence-based

medical devices and in training the health care workforce to use them safely and effectively (21).

Figure 8. Age-standardized Diabetes mellitus mortality rates (per 100 000 population) for both sexes by country, 2019



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etes I.IV Availability of and access to medical devices for NCDs

Medical devices are indispensable for effective diagnosis, treatment, monitoring and rehabilitation of illness

and disease. An estimated 1.5 million different medical devices exist, in more than 20 000 types of generic

device groups (24, 25). Assistive devices are essential to ensure functioning, independence, and well-being of

individuals living with stroke, diabetes, and other chronic conditions. In 2008, WHO initiated the first global

effort to identify global needs for medical devices, with the aim of prioritizing and selecting the essential

and affordable medical devices of greatest importance, taking into account the disease burden of individual

countries. In 2010, a first global survey on medical devices revealed major gaps in the availability of and access

to medical devices in countries (26), as well as vast discrepancies between countries regarding the existence

of regulatory capacities, national policies, national lists, and technical specifications for procurement and

reimbursement of medical devices. The update of these data was presented in the WHO Global atlas of medical devices 2010 (28). Examples of global availability of high-cost medical devices per 1 million population

are available in the Global atlas of medical devices (28).

WHO estimates that 1 billion people need assistive devices globally, but only 1 in 10 people has access to

the devices they need (27). WHO published the Priority Assistive Products List with the goal to improve the

availability and affordability of assistive devices in countries.

Many basic technologies for the early detection, diagnosis and monitoring of NCDs were reported as being

generally available in primary care facilities in the public health sector: 98% for blood pressure measurement,

92% for height and weight measurement, and 88% for blood glucose measurement (29). Urine strips for

albumin assay, and total cholesterol measurement were also reported as being generally available (69%) in

most countries. However, for the remainder of the basic technologies, fewer than half of countries reported

them as being generally available: for example, HbA1c (53% of countries) and remaining tests (such as dilated

fundus examination, foot vibration perception by tuning fork and peak flow measurement spirometry were

reported as being generally available in 45–50% of countries.

The six essential technologies for the early detection, diagnosis and monitoring of NCDs comprise devices

for measurement of height, weight, blood glucose, blood pressure, and total cholesterol, and urine strips for

albumin assay. The general availability of the six essential basic technologies is shown in Figure 9 by WHO

region and World Bank income group (height and weight are combined). Total cholesterol measurement was

highly variable across regions and income groups with significantly lower availability reported in the South-

East Asia (45% of countries) and African regions (32% of countries), and countries of the low income (26%)

and low-middle-income (37%) groups. By contrast, blood pressure measurement was consistently available

in 90% or more of countries across all regions and income groups. Just over half of countries (53%) reported

all six essential tests and procedures (measurement of height, weight, blood pressure, blood glucose, and

total cholesterol, as well as urine strips for albumin assay) being generally available. Marked disparities were

evident across the income groups: 96% of high-income countries reported all six tests and procedures were

generally available compared with 16% (or just five) low-income countries. Figure 10 shows the percentage

of countries with procedures generally available for treating NCDs in the public health care system, by World

Bank income group. Disparities across income groups are marked: all but 10 high-income countries reported

six or seven of the seven procedures as being generally available, while 55% of low-income countries reported

no procedures as being generally available, and a further third reported just one.

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Figure 9. Percentage of countries with availability of essential technologies for early detection, diagnosis and monitoring of NCDs in the primary care facilities of the public and private health sectors, by WHO region and World Bank income group

Source: World Health Organization (29).

Figure 10. Percentage of countries with procedures generally available for treating NCDs in the public health care system, by World Bank income group

Source: World Health Organization (29).

Results

51

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angiotensin II receptor blockers (ARBs) being generally available, but only 36% of countries in the $IULFDQ�5HJLRQ�UHSRUWHG�VXFK�DYDLODELOLW\��/LNHZLVH��VLJQLåFDQW�GLIIHUHQFHV�ZHUH�REVHUYHG�EHWZHHQ�WKH�UHJLRQV�LQ�DYDLODELOLW\�RI�VWDWLQV�DQG�VWHURLG�LQKDOHUV��the latter was reported as being generally available E\�MXVW�IRXUbFRXQWULHV�LQ�WKH�6RXWK�(DVW�$VLD�5HJLRQ��and by less than a quarter of countries in the African Region. Disparities across the income groups were also marked: 93% of countries in the high-income group reported having all 11 essential medicines DV� JHQHUDOO\� DYDLODEOH�� WKH� UHPDLQGHU� RI� FRXQWULHV�in this income group reported having a minimum of eight. In contrast, 10% of low-income countries �MXVW� �b FRXQWULHV�� UHSRUWHG�KDYLQJ� DOO� �� HVVHQWLDO�PHGLFLQHV�JHQHUDOO\�DYDLODEOH��MXVW�RYHU��KDG�åYH�or fewer generally available.

Results

53

Procedures for treating NCDs

As in previous rounds of the survey, countries were asked to report on the availability of key procedures for treating NCDs in the publicly funded health system �ÙJHQHUDOO\�DYDLODEOHÚ�ZDV�GHåQHG�DV�UHDFKLQJ�DW�OHDVW�50% of patients in need). Renal replacement by dialysis (71% of countries) and thrombolytic therapy (65% of countries) were procedures most widely reported as EHLQJ�JHQHUDOO\�DYDLODEOH�� UHWLQDO�SKRWRFRDJXODWLRQ��stenting and coronary bypass were reported by just over 50% of countries as being generally available �)LJXUHb �� 5HQDO� UHSODFHPHQW� E\� WUDQVSODQWDWLRQ�and bone marrow transplant were available to the majority of patients in need in less than half of countries worldwide (40% and 31% of countries, respectively). Disparities across income groups were even more marked than for essential medicines: all but 10 high-income countries reported six or seven of the seven procedures as being generally available, while

55% of low-income countries reported no procedures as being generally available, and a further third reported just one. These procedures were reported as being most widely available in the European Region ��Ô��RI�FRXQWULHV��DQG�OHDVW�ZLGHO\�DYDLODEOH�LQ�WKH�$IULFDQ�5HJLRQ��Ô��'LDO\VLV�ZDV�WKH�PRVW�widely available procedure in all regions and income JURXSV��H[FHSW�IRU�WKH�:HVWHUQ�3DFLåF�5HJLRQ�ZKHUH�thrombolytic therapy and retinal photocoagulation were more widely available. The 2019 survey was WKH� åUVW� VXUYH\� LQ� ZKLFK� FRXQWULHV� ZHUH� DVNHG�about availability of bone marrow transplantation. This revealed considerable gaps in availability: while over two thirds of countries in the European Region reported bone marrow transplantation as being generally available, a third or fewer of countries in all other regions reported this procedure reaching the majority of patients in need, including just one country in each of the African and South-East Asia regions.

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Results

53






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Results

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10

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etes Further reading

The sources shown in Figure 11 lists WHO’s guidelines for cardiovascular disease management, they were

used to compile the present publication. Other sources will be listed in each specific section.

Figure 11. WHO sources for cardiovascular disease management

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

https://apps.who.int/iris/bitstream/handle/10665/42602/9241562242.pdf?sequence=1&isAllowed=y

https://apps.who.int/iris/bitstream/handle/10665/43222/9241546727.pdf?sequence=1&isAllowed=y

https://apps.who.int/iris/bitstream/handle/10665/43787/9789241547260_eng.pdf?sequence=1&isAllowed=y

https://www.who.int/ncds/management/WHO_ISH_Risk_Prediction_Charts.pdf?ua=1





https://apps.who.int/iris/bitstream/handle/10665/79059/WHO_DCO_WHD_2013.2_eng.pdf?sequence=1&isAllowed=y

https://apps.who.int/iris/bitstream/handle/10665/252661/9789241511377-eng.pdf?sequence=1&isAllowed=y

https://apps.who.int/iris/bitstream/handle/10665/334186/9789240009226.eng.pdf?sequence=1&isAllowed=y

https://apps.who.int/iris/bitstream/handle/10665/334186/9789240009226.eng.pdf?sequence=1&isAllowed=y

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In chronological order: 1. Intergrated management of cardiovascular risk. Report of a World Health Organization meeting,

2. Avoiding heart attacks and strokes. Don’t be a victim, protect yourself,

3. Prevention of cardiovascular disease. Guidelines for assessment and management of cardiovascular risk,

4. Prevention of cardiovascular disease (CVDs). Pocket guidelines for assessment and

management of CVD risk,

5. World Health Organization/ International Society of Hypertension Risk Prediction Charts,

6. Package of essential NCD interventions for primary health care: cancer, diabetes, heart disease and

stroke, chronic respiratory disease,

7. Guidelines for primary health care in low-resource settings. Cancer, diabetes, heart disease and stroke,

chronic respiratory disease,

8. Implementation tools. Package of Essential Noncommunicable (PEN) disease interventions for primary

health care in low-resource settings,

9. A global brief on hypertension. Silent killer, global public health crisis,

10. HEARTS: Technical package for cardiovascular disease management in primary health care.

11. Six modules that make up the HEARTS Technical package. Healthy-lifestyle counseling, Evidence-based

treatment protocols, Access to essential medicines and technology, Risk-based charts, Team-based care

and, Systems for monitoring.

12. WHO package of essential noncommunicable (PEN) disease interventions for primary health care.

12

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dise

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etes The methodology used to select the priority medical devices for cardiovascular diseases and diabetes was

based on the methodology defined by WHO to select the previously published lists of priority medical

devices (30, 31). The process involves a review of clinical guidelines to define interventions and identification

of medical devices required to perform each intervention by level of care. However, there were very few WHO

guidelines available for the management of cardiovascular diseases and diabetes; the methodology therefore

had to be modified accordingly. The following overview presents the milestones and the adaptation of the

methodology throughout the process that led to the present publication.

Figure 12. Methodology: from disease identification to dissemination of information

2017

The first draft selection of medical devices for cardiovascular diseases, including different clinical services, took

place. This project was done in parallel with work carried out by the WHO PAHO, following the methodology

and structure of the priority medical devices for cancer management (30).

2018

In a meeting to review the progress made in developing the list of priority medical devices for cardiovascular

interventions, it was confirmed that many devices used for the management of cardiovascular diseases and

their complications are also used in the management of stroke and diabetes complications. As a result, it

was decided that the priority interventions and according medical devices for all three diseases were to be

combined in a single publication using ad hoc methodology.

In the next step, medical conditions arising from cardiovascular diseases and diabetes were identified using

WHO publications and available evidence based clinical guidelines. The selected types of conditions were

matched with the WHO International Classification of Diseases, 11th Revision (ICD-11) (32), while the clinical

interventions were matched with the WHO International Classification of Health Interventions (ICHI) codes.

The types of conditions included the following (colour coded by category – see introductory section).

Disease areas

Clinical guidelines

Priority clinical interventions

Final list of priority medical

devices

Dissemination

Publication

• Cardiovascular

• Stroke

• Diabetes

Types of conditions

Search and selection according to the NEATS Instrument

ICD-11 codes

ICHI codes

Medical devices

Consultation with Experts

Public consultation

Define information

for databases and systems*

* https://medevis.test.evidenceprime.com

II. Methodology

https://medevis.test.evidenceprime.com/

13

II. Meth

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Cardiovascular disease (except stroke)

• essential hypertension

• coronary atherosclerosis

• heart failure

• cardiomyopathy

• valvular disease

• congenital heart disease

• arrhythmia

• arterial disease

• deep vein thrombosis

• pulmonary embolism

Stroke

• cerebrovascular disease with no acute symptoms

• cerebral ischaemia, including transient ischaemic attack

• retinal vascular occlusion

• intracerebral haemorrhage

• subarachnoid haemorrhage

• certain specified cerebrovascular diseases

• cerebrovascular abnormalities

Diabetes

• diabetes mellitus type unspecified

• hypoglycaemic emergency

• hyperglycaemic emergency

• diabetic nephropathy

• diabetic retinopathy

• diabetic neuropathy

• diabetic foot

WHO staff prepared an initial list of interventions for each condition based on the ICHI codes and proposed

a list of medical devices for each of them, to be reviewed by experts. This first draft was presented in a

workshop and session at the fourth WHO Global Forum on Medical Devices in India, December 2018 (33).

2019

Step 1. Selection of evidence based clinical guidelines for cardiovascular diseases and diabetes was performed

by Cochrane Netherlands (see Annex 2).

Step 2. A multidisciplinary group of experts in cardiovascular diseases, diabetes and medical devices

was assembled to review the draft list of clinical interventions and priority medical devices. Each clinical

intervention was grouped based on the level of care: primary, secondary or tertiary level.

Step 3. Systematic reviews of selected international guidelines were performed to identify clinical interventions.

The selected clinical interventions were classified into different units of health care services: 1. clinical

assessment, 2. emergency care, 3. clinical laboratories, 4. other specialized diagnostic services, 5. medical

imaging, 6. surgery, 7. non-surgical interventions, 8. hospitalization, 9. intensive care unit, 10. rehabilitation,

11. palliative care.

Step 4. The list of clinical interventions was validated using evidence based clinical guidelines as a

reference standard.

Step 5. A group of interdisciplinary experts was selected and invited to attend a consultation meeting on 11

and 12 July 2019 in Geneva, Switzerland. Depending on the individual expertise, participants joined one of the

three working groups formed to discuss topics relevant to cardiovascular diseases or diabetes. After the two

days of discussions, the following meeting outcomes were achieved.

• The project timeline was reviewed and approved.

• The methodology for selection of evidence based clinical guideliness to support the identification of

priority medical devices was presented and approved.

• Experts identified and agreed on a draft list of priority clinical interventions for cardiovascular


• Experts identified and agreed on a draft list of priority medical devices for cardiac and vascular


• Next steps and country implementation strategies were discussed in the context of different

health care settings.

14

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etes Step 6. A draft document including background, methodology, and lists of clinical interventions and priority

medical devices was developed and reviewed by an extended group of experts. Medical devices were grouped

as either general or specific, depending on their applicability to more than one disease.

2020

Step 1. Global on-line consultations took place on the list of priority medical devices for cardiovascular


Step 2. Expert group teleconferences were organized to review comments and finalize the list of

priority medical devices.

Step 3. Technical editing and design were completed.

Step 4. Digital publication was completed.

II.I Search and selection of clinical guidelinesDue to the lack of clinical guidelines developed by WHO for the management of cardiovascular diseases and

diabetes, WHO commissioned Cochrane Netherlands to identify and select good-quality clinical guidelines

addressing the diseases within the scope of this project.

A broad search was performed to identify English language clinical guidelines on prevention, diagnosis,

treatment or rehabilitation for cardiovascular diseases and diabetes published between 2017 and 2019.

Guidelines from international organizations as well as guidelines developed at national level, including in low-

and middle-income countries, were of interest.

The following guideline resources were searched to identify guidelines from North America, Europe, Australia,

Canada, and low- and middle-income countries:

• Emergency Care Research Institute Guidelines Trust

• Turning Research into Practice database

• Global Health Library

• Guidelines International Network: International Guidelines Library

• Canadian Agency for Drugs and Technologies in Health reports

• National Institute for Health and Care Excellence evidence search

• World Heart Federation

• International Diabetes Federation

• World Stroke Organization.

A two-step search approach was taken. The information specialist of Cochrane Netherlands performed an

initial search using general terms for the conditions of interest (cardiovascular and diabetes) and selected

guidelines based on relevance to the topics. Search terms used are reported in Annex 2.

The preselected clinical guidelines were assessed according to the following aspects:

• whether the guideline contained details regarding interventions or medical devices for specific

categories of disease;

• whether the guideline addressed prevention, diagnosis, treatment or rehabilitation;

• items of the National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards (NEATS)

instrument (Annex 3).

Based on these assessments, the most recent and highest-quality clinical guideline addressing a specific

category of disease was selected.

For specific categories of disease that were not covered by one of the selected guidelines, an additional

search was performed using terms and synonyms for that specific category of disease. The identified clinical

guidelines were assessed as described above.

15

II. Meth

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II.II Selected clinical guidelines

Cardiovascular diseases (except stroke)

Seventeen guidelines were assessed after the initial searches (Table 1). Additional searches were performed

for the disease categories of “coronary atherosclerosis” and “arterial disease”, which led to the assessment

of three additional guidelines.

Of the 20 guidelines assessed, 14 were selected based on an average score of 3 points or higher on the

NEATS items (Annex 3).

Table 1. List of selected clinical guidelines for cardiovascular diseases

ICD-11 code

Type of condition Guidelines [click to open link]

BA00 Essential hypertension American College of Cardiology, American Heart Association (2017)Hypertension Canada (2018)American College of Cardiology, American Heart Association (2016)

BA80 Coronary atherosclerosis

European Society of Cardiology, European Association for Cardio-Thoracic Surgery (2019)American College of Cardiology, American Heart Association (2016)

BD1Z Heart failure American College of Cardiology, American Heart Association, Heart Rhythm Society (2017)American College of Cardiology, American Heart Association, Heart Failure Society of America (2017)National Institute for Health and Care Excellence (2018)National Institute for Health and Care Excellence (2017)

BC43.Z Cardiomyopathy American College of Cardiology, American Heart Association, Heart Rhythm Society (2017)

BC0Z Valvular disease American College of Cardiology, American Heart Association, Heart Rhythm Society (2017)American College of Cardiology, American Heart Association (2018)

LA8Z Congenital heart disease

American College of Cardiology, American Heart Association, Heart Rhythm Society (2017)American College of Cardiology, American Heart Association (2018)

BC9Z Arrhythmia American College of Cardiology, American Heart Association, Heart Rhythm Society (2017)European Society of Cardiology, European Association for Cardio-Thoracic Surgery (2019)Healthcare Improvement Scotland (2018)National Institute for Health and Care Excellence (2017)

BD52.7 Arterial disease American College of Cardiology, American Heart Association (2016)

BD71 Deep vein thrombosis Korean Society for Vascular Surgery (2016)National Institute for Health and Care Excellence (2019)National Institute for Health and Care Excellence (2018)

BB00 Pulmonary embolism British Thoracic Society (2018)National Institute for Health and Care Excellence (2018)

https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(17)41519-1


https://linkinghub.elsevier.com/retrieve/pii/S0828-282X(18)30183-1



https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehy394






https://www.ahajournals.org/doi/10.1161/CIR.0000000000000509?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

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https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000603










https://www.sign.ac.uk/media/1089/sign152.pdf

https://www.nice.org.uk/guidance/mtg33



http://www.vsijournal.org/journal/DOIx.php?id=10.5758/vsi.2016.32.3.77

https://www.nice.org.uk/guidance/ipg651


https://thorax.bmj.com/lookup/pmidlookup?view=long&pmid=29898978


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Twelve guidelines were assessed after the initial searches (Table 2). Additional searches were performed for

the disease categories of “retinal vascular occlusion” and “subarachnoid haemorrhage”, which led to the

assessment of two additional guidelines.

Of the 14 guidelines assessed, nine were selected based on an average score of 3 points or higher on the

NEATS items (Annex 3).

Table 2. List of selected clinical guidelines for stroke

ICD-11 code Type of condition Guidelines [click to open link]

8B21 Cerebrovascular disease with no acute symptoms

Stroke Foundation (2017)European Stroke Organisation (2018)

8B10, 8B11 Cerebral ischaemia including transient ischaemic attack

American Heart Association, American Stroke Association (2018)Stroke Foundation (2017)British Medical Journal (2018)European Stroke Organisation, European Society for Minimally Invasive Neurological Therapy (2019)European Stroke Organisation (2018)Korean Stroke Society (2016)National Institute for Health and Care Excellence (2019)Heart and Stroke Foundation of Canada (2018)European Academy of Neurology, European Stroke Organisation (2018)

8B00 Intracerebral haemorrhage

Stroke Foundation (2017)European Stroke Organisation (2018)National Institute for Health and Care Excellence (2019)European Academy of Neurology, European Stroke Organisation (2018)

8B01 Subarachnoid haemorrhage

European Stroke Organisation (2018)European Academy of Neurology, European Stroke Organisation (2018)

https://informme.org.au/en/Guidelines/Clinical-Guidelines-for-Stroke-Management-2017

https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/31008333/

https://www.ahajournals.org/doi/10.1161/STR.0000000000000158?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed


https://www.bmj.com/content/bmj/363/bmj.k5130.full.pdf




https://www.j-stroke.org/journal/view.php?number=116


https://journals.sagepub.com/doi/full/10.1177/1747493018786616

https://core.ac.uk/reader/161699931?utm_source=linkout










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Diabetes

WHO staff provided a list of 25 diabetes guidelines (Table 3) of a previous commissioned guideline search, of

which 13 guidelines published from 2017 onwards were assessed. An additional 15 guidelines were identified

by the guideline search. As all specific disease categories were covered by the identified guidelines, no

additional searches were performed.

Of the 28 guidelines assessed, nine were selected based on an average score of 3 points or higher on the NEATS

items (Annex 3). The guideline marcked with a “*” in the following table are meant for diabetes type two only.

Table 3. List of selected clinical guidelines for diabetes

ICD-11 code Type of condition Guidelines [click to open link]

5A14 Diabetes mellitus, type unspecified

Diabetes Canada (2018)National Institute for Health and Care Excellence (2017)*Healthcare Improvement Scotland (2017)*Department of Veterans Affairs, Department of Defense (2017)World Health Organization (2018)American College of Physicians (2017)*American Diabetes Association (2019)

5A21 Hypoglycaemic emergency

Healthcare Improvement Scotland (2017)*World Health Organization (2018)American College of Physicians (2017)*American Diabetes Association (2019)

5A20, 5A22 Hyperglycaemic emergency

Diabetes Canada (2018)World Health Organization (2018)American College of Physicians (2017)*American Diabetes Association (2019)

GB61.Z Diabetic nephropathy Healthcare Improvement Scotland (2017)*Department of Veterans Affairs, Department of Defense (2017)World Health Organization (2018)American College of Physicians (2017)*American Diabetes Association (2019)

9B71.0 Diabetic retinopathy Healthcare Improvement Scotland (2017)*Department of Veterans Affairs, Department of Defense (2017)American College of Physicians (2017)*American Diabetes Association (2019)

8C03.0, 8D88.1

Diabetic neuropathy Diabetes Canada (2018)National Institute for Health and Care Excellence (2018)Healthcare Improvement Scotland (2017)*Department of Veterans Affairs, Department of Defense (2017)American College of Physicians (2017)*American Diabetes Association (2019)

BD54, FA38.10 Diabetic foot Diabetes Canada (2018)Healthcare Improvement Scotland (2017)*World Health Organization (2018)American Diabetes Association (2019)

https://www.sciencedirect.com/journal/canadian-journal-of-diabetes/vol/42/suppl/S1



https://www.healthquality.va.gov/guidelines/CD/diabetes/VADoDDMCPGFinal508.pdf

https://apps.who.int/iris/handle/10665/272433

https://www.acpjournals.org/doi/10.7326/M16-1860?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

https://care.diabetesjournals.org/content/42/Supplement_1



















https://www.nice.org.uk/guidance/cg173









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After the clinical guideline search and selection using specified criteria, gaps in the coverage of certain types

of conditions were identified. To fill in the gaps, the working group experts proposed the list of guidelines set

out in Table 4, including guidelines published before the period selected for the initial search (2017–2019).

Table 4. List of additional clinical guidelines

Disease Provider organization

Publication year Title [click to open link]

Diabetes International Council of Ophthalmology

2017 International Council of Ophthalmology guidelines for diabetic eye care

Diabetes Ministry of Health, Colombia

2016 Guía de práctica clínica para el diagnóstico, tratamiento y seguimiento de la diabetes mellitus tipo 2 en la población mayor de 18 años [Clinical practice guide for the diagnosis, treatment and monitoring of type 2 diabetes mellitus in the population over 18 years of age]

Stroke World Stroke Organization

2016 Global stroke guidelines and action plan: a road map for quality stroke care

Stroke American Heart Association Stroke Council

2015 Guidelines for the management of spontaneous intracerebral haemorrhage

Stroke European Stroke Organisation

2014 European Stroke Organisation guidelines for the management of spontaneous intracerebral haemorrhage

Stroke European Stroke Organisation

2012 European Stroke Organisation guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage

Stroke South African Stroke Society

2010 South African guideline for management of ischaemic stroke and transient ischaemic attack 2010: a guideline from the South African Stroke Society (SASS)

Cardio-vascular diseases

European Society of Cardiology, European Society of Hypertension

2018 Guidelines for the management of arterial hypertension

http://www.icoph.org/enhancing_eyecare/diabetic_eyecare.html

http://www.icoph.org/enhancing_eyecare/diabetic_eyecare.html

https://colombiamedica.univalle.edu.co/index.php/comedica/article/view/2207






https://www.world-stroke.org/publications-and-resources/resources/roadmap-to-delivering-quality-stroke-care-resource

https://www.world-stroke.org/publications-and-resources/resources/roadmap-to-delivering-quality-stroke-care-resource

https://www.ahajournals.org/doi/10.1161/str.0000000000000069

https://www.ahajournals.org/doi/10.1161/str.0000000000000069

https://journals.sagepub.com/doi/10.1111/ijs.12309?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed



https://www.karger.com/?DOI=10.1159/000346087



https://journals.sagepub.com/doi/full/10.1111/j.1747-4949.2011.00629.x



https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Arterial-Hypertension-Management-of

https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Arterial-Hypertension-Management-of

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II.IV Relevant WHO publicationsRelevant documents published by WHO in relation to the diseases targeted in the present project were also

consulted and referred to. The list of WHO documents is presented in Table 5.

Table 5. Relevant WHO publications

Publication title Publication year Interest

Package of essential noncommunicable (PEN) disease interventions for primary health care in low-resource settings (16)

2010 Cardiovascular diseases, diabetes

Prevention of cardiovascular disease (CVDs): pocket guidelines for assessment and management of CVD risk (9)

2007 Cardiovascular diseases, stroke

Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health (31)

2015 General assessments, surgery

WHO list of priority medical devices for cancer management (30) 2017 General laboratory, imaging, surgery

Second WHO model list of essential in vitro diagnostics (34) 2019 Laboratory tests, point-of-care diagnostics

Prevention of blindness from diabetes mellitus: report of a WHO consultation (35)

2006 Blindness from diabetes mellitus

HEARTS: technical package for cardiovascular disease management in primary health care (36)

2016 Cardiovascular diseases

II.V Selection of the clinical interventionsWhenever possible, the selected clinical interventions were matched with the WHO International Classification

of Health Interventions (ICHI) (37). The selected clinical interventions were classified into different units of

health care services: 1. clinical assessment, 2. emergency care, 3. clinical laboratories, 4. other specialized

diagnostic services, 5. medical imaging, 6. surgery, 7. non-surgical interventions, 8. hospitalization, 9. intensive

care unit, 10. rehabilitation, 11. palliative care. A full list of selected priority clinical interventions can be

found in Tables 6–9.

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The following table lists the general priority clinical interventions. Each intervention was matched with the

WHO International Classification of Health Interventions (ICHI) (37) if existing. On the level of care column, it

is presumed that 1, 2, and 3 indicate primary, secondary and tertiary level of care accordingly, and the space

is ticked when the intervention should take place under that level.

Table 6. General priority clinical interventions

ICHI codes [clickable]

Clinical interventionsLevel of care

1 2 3

Clinical assessmentPZA.AB.ZZ Anthropometric measurement (height, weight, body mass index, waist and

hip circumference)X X X

HT2.AA.ZZ Assessment of cardiovascular functions X X X

JTB.AA.ZZ Assessment of respiratory functions X X X

BZZ.AA.AH Direct and indirect ophthalmoscopy X X X

ITA.AB.AF Measurement of blood pressure X X X

ETG.AB.ZZ Measurement of body temperature X X X

BZZ.AA.AH Test for visual acuity X X X

Clinical laboratoryDIA.JH.AF Erythrocyte sedimentation rate (ESR) X X X

DIA.JH.AF Haemoglobin (Hb) X X X

DIA.JH.AF Haematocrit (Hct) X X X

DIA.JH.AF Platelet count X X X

DIA.JH.AF Complete blood count automated X X

DIA.JH.AF White blood cell count/differential leucocyte count X X

NTC.AA.ZZ Renal function tests (albumin, blood urea nitrogen, creatinine, phosphate, urine chemistry)

X X

DIA.JH.AF Peripheral blood film examination X X

DIA.JH.AF Glucose/point-of-care analyser X X X

DTA.AB.ZZ Serum bicarbonate/blood pH and gases X X

DIA.JH.AF Lipid profile X X

DIA.JH.AF Electrolytes (sodium, potassium, chloride) X X

DIA.JH.AF Creatinine and albumin to estimate glomerular filtration rate (GFR) and albumin–creatinine ratio (ACR)

X X X

DIA.JH.AF Tests for serum triiodothyronine (T3), thyroxine (T4), thyroid-stimulating hormone (TSH)

X X

NTC.AB.ZZ Tests for urinary creatinine, urinary urea, urinary electrolytes (sodium, potassium, chloride) and urinary osmolarity

X X

Medical imagingPZA.BA.BA X-ray imaging X X

Fluoroscopic imaging X

PAK.BA.BJ; IZZ.BA.BJ; KMA.BA.BJ; PAK.BA.BJ

Ultrasound scan X X

PAK.BA.BC Computed tomography (CT) scan X

MZZ.BA.BH Magnetic resonance imaging (MRI) X

III. Priority medical devices by clinical area

https://mitel.dimi.uniud.it/ichi/%23http://id.who.int/ichi/entity/364117693





























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Clinical interventionsLevel of care

1 2 3

HospitalizationInpatient admission X X

Clinical and paraclinical monitoring (scheduled tests) X X

Medical treatment and wound care X X X

Administration of medication (administration of oral and parenteral treatment)

X X X

Intensive care unitJTB.DE.AC Mechanical ventilation X X

PZA.DD.AC Oxygen therapy X X X

HT2.AA.ZZ; ITA.AI.AF

Continuous multiparametric cardiac monitoring with non-invasive/invasive blood pressure monitoring and ambulatory blood pressure monitoring

X X

JTB.AI.ZZ Monitoring of oxygen saturation X X X

HTB.SC.AH Defibrillation and external pacemaker/resuscitation X X X

PAK.BA.BJ; IZZ.BA.BJ; KMA.BA.BJ

Ultrasound scan X X

JZZ.DL.AC Intubation X X

PZX.DB.AEPZX.DB.AF

Continuous infusion and application of supportive drugs X X

PZX.AH.XA Blood gas analysis X X

JCH.BA.BA Imaging of the chest X X X

PZX.AH.XA Point-of-care glucose test X X X
















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etes The following tables lists the specific priority clinical interventions by disease following the colour code. Each

intervention was matched with the WHO International Classification of Health Interventions (ICHI) (37) if existing. On the level of care column, it is presumed that 1, 2, and 3 indicate primary, secondary and tertiary

level of care accordingly, and the space is ticked when the intervention should take place under that level.

The type of conditions column gives more specificality about what conditions each intervention covers.

Table 7. Priority clinical interventions for cardiovascular diseases except stroke

Types of conditionsA – BA00 Essential hypertension

B – BA80 Coronary atherosclerosis

C – BD1Z Heart failure

D – BC43.Z Cardiomyopathy

E – BC0Z Valvular disease (including infectious endocarditis)

F – LA8Z Congenital heart disease

G – BC9Z Arrhythmia

H – BD52.7 Arterial disease

I – BD71 Deep vein thrombosis

J – BB00 Pulmonary embolism

Cardiovascular diseases


Clinical interventionsType of condition Level of

care

A B C D E F G H I J 1 2 3

Clinical assessment HTB.AC.AH Electrocardiography test X X X X X X X X X X X X X

Clinical laboratoryDTA.AB.ZZ Prothrombin time and international

normalized ratio (PT/INR), point-of-care testing

X X X X X X X

DTA.AB.ZZ Partial thromboplastin time (PTT), also known as activated partial thromboplastin time (APTT)

X X X X X X

HZZ.ZZ.AZ B-type natriuretic peptide (BNP) test, point-of-care testing

X X X X X X X

HZZ.ZZ.AZ Test for cardiac biomarkers (troponin T/I), point-of-care testing

X X X X X X X X X

HZZ.ZZ.AZ Test for cardiac biomarkers (troponin, CK-MB)

X X X X X X X X

DTA.AB.ZZ D-dimer, point-of-care testing X X X X

Other specialized diagnosticsHTM.AF.ZZ Exercise cardiac stress test device X X X X X X X

Medical imagingHFD.BA.BG Positron emission tomography (PET) of

myocardiumX X X X X

HFD.BA.BF Stress and rest test – single photon emission computed tomography (SPECT)

X X X X

HZZ.BA.BJ Stress and rest – transthoracic echocardiography with or without contrast

X X X X X X X X X X X

HZZ.BA.AC Transoesophageal echocardiography X X X X X X X X X X X













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Clinical interventionsType of condition Level of

care

A B C D E F G H I J 1 2 3HIA.BA.BB; ICA.BA.BB; IFA.BA.BB; IDA.BA.BB; IEA.BA.BB; HZA.BA.BB; HZB.BA.BB; IDB.BA.BB; ICD.BA.BB; IED.BA.BB;IFD.BA.BB; IZD.BA.BB

X-ray imaging (cardiac and peripheral angiography)

X X X X X X X X X X

HIA.BA.BB; ICA.BA.BB; IFA.BA.BB; IDA.BA.BB; IEA.BA.BB; HZA.BA.BB; HZB.BA.BB; IDB.BA.BB; ICD.BA.BB; IED.BA.BB;IZD.BA.BB

Digital subtraction angiography (DSA) X X X X X X X X X X

HIA.LG.AF; HIA.LH.AF

Coronary angioplasty with or without stenting

X X X X

HDG.LG.AF;HDF.LG.AF; HDE.LG.AF; HDH.LG.AF

Percutaneous balloon valvuloplasty (aortic, mitral, pulmonary and tricuspid)

X X X

IFA.LG.AF; IFA.LH.AF; ICA.LG.AF; ICA.LH.AF

Peripheral angioplasty with or without stenting

X X X

IZZ.BA.BJ; IAA.BA.BJ

Doppler ultrasound of peripheral vascular system

X X X X

SurgeryHAD.LG.AF Balloon atrial septostomy X X

HIK.LG.AF Balloon dilatation for coarctation X X

HFC.DN.AA; HFC.DN.AF

Cardiac pacemaker implantation X X

HFC.DN.AA; HFC.DN.AF

Cardiac resynchronization therapy (CRT), defibrillator implantation

X X X X

IZA.LG.AF; IZA.LH.AF

Angioplasty with or without stenting X X X X X

HIA.LI.AA Coronary artery bypass grafting X X

HFC.AF.AF; HFC.GA.AF

Cardiac electrophysiology and catheter ablation

X X X

HZM.ML.AA Correction of congenital heart disease X X

HDE.MK.AA; HDF.MK.AA; HDG.MK.AA;HDH.MK.AA

Repair of heart valve X X X

HZB.AB.AF Right heart cardiac catheterization X X X X X X X

Intensive Care UnitIZA.DB.AF; IZD.DB.AF

Thrombolysis X X X X X X

HZZ.DN.AF Intra-aortic counterpulsation X X X

HFC.DL.AF Temporary transvenous pacing X X























































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Types of conditionsA – 8B21 Cerebrovascular disease with no acute symptoms

B – 8B10, 8B11 Cerebral ischaemia including transient ischaemic attack

C – 9B74 Retinal vascular occlusion

D – 8B00 Intracerebral haemorrhage

E – 8B01 Subarachnoid haemorrhage

F – 8B22, 8B23 Certain specified cerebrovascular diseases

Stroke


Clinical interventionType of condition

Level of care

A B C D E F 1 2 3

Clinical assessment AZZ.AA.AH Neurological assessment X X X X X X X X

Clinical laboratory AZZ.ZY.AZ Cerebrospinal fluid (CSF) bilirubin spectrophotometry X X

DTA.AB.ZZ Prothrombin time and international normalized ratio (PT/INR), point-of-care testing

X X X X X X X X

Other specialized diagnosticsAAA.AF.AH Electroencephalography X X X X X X

Medical imagingIAA.BA.BJ Doppler imaging of extracranial vessels X X X X X X

IBA.BA.BJ Doppler imaging of intracranial vessels X X X X X X X

BAM.BA.BC Optical coherence tomography X X X

BZA.BA.BJ Eye and orbit ultrasound scan X X X X X X X

BCA.BA.BE Fluorescein angiography or angioscopy of posterior chamber of eye

X X

IBA.LH.AF Dilatation with insertion of stent or prosthesis of artery of head and neck

X X X X

IBA.LA.AF Endovascular coiling X X X X

IBA.JE.AF Endovascular extraction of obstruction from head and neck vessel (e.g. thrombectomy)

X X X

IBB.LG.AF Percutaneous angioplasty of carotid artery, extracranial

SurgeryMAA.JJ.AA Craniectomy X X X X X

MAA.FA.AA Craniotomy X X X X

AAG.JB.AA Extraventricular drain placement X X X X X

IBA.LA.AF Endovascular embolization or occlusion of head and neck vessels

X X X X

HAA.DN.AF Implantation of left atrial appendage device X X X X

HAD.ML.AA Repair of atrial septal defect of heart with graft or prosthesis

X X X X X

IBA.LA.AF Surgical aneurysm clipping X X X X

IBA.DB.AF Thrombolysis of artery of head and neck (percutaneous transluminal)

X X X

IAA.DB.AF Thrombolysis of intracranial artery (percutaneous transluminal)

X X X





















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Clinical interventionType of condition

Level of care

A B C D E F 1 2 3

Non-surgical interventions IZZ.ZY.ZZ Intermittent pneumatic lower limb compression X X X X X X

KBF.DL.AJ Percutaneous endoscopic gastrostomy (PEG) X X X X X X

HospitalizationIAA.DB.AF Emergency or ICU procedure - patients admitted to

stroke unit after thrombolysis X X X X

PZZ.ZY.ZZ Physical therapy/rehabilitation X X X X X X X

Intensive care unitAAA.AI.AE Intracranial pressure monitoring X X X X X

AAA.AI.AE Near-infrared spectroscopy monitor X X X X X





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Types of conditionsA – 5A14 Diabetes mellitus, type unspecified

B – 5A21 Hypoglycaemic emergency

C – 5A20, 5A22 Hyperglycaemic emergency

D – GB61.Z Diabetic nephropathy

E – 9B71.0 Diabetic retinopathy

F – 8D88.1 Diabetic neuropathy

G – BD54 Diabetic foot

Diabetes


Clinical interventionType of condition Level of

care

A B C D E F G 1 2 3

Clinical assessmentAVE.AA.ZZ Examining vibration perception in the feet, motor

function and sensory perception testing X X X X X X

IZZ.AA.ZZ Measuring ankle-brachial pressure index X X X X X X

KAZ.AE.AC Periodontal examination X X X X

PZX.AH.XA Point-of-care blood glucose test X X X X X X X X X X

PZX.AH.XA Point-of-care blood ketone test X X X X X X

Clinical laboratoryNAM.AA.ZZ Urinalysis test strips plus microscopy X X X X X

NAM.AA.ZZ Spot urine test for urinary infection X X X X X X

Haemoglobin A1c (HbA1c), point-of-care testing X X X X X X X X X

PZX.AH.XB; NTC.AB.ZZ

Urine glucose and ketones X X X X X X X

Other specialized diagnosticsBZZ.AA.AH Direct or indirect Ophthalmoscopy X X X X X

Medical imagingIZZ.BA.BJ Doppler ultrasound of peripheral vascular system X X X

BCA.BA.BE Fluorescein angiography X X X

BCA.BA.AH Fundus photography with a non-mydriatic camera and interpretation of results (locally or remotely) X X X

BZZ.AA.AH Optical coherence tomography (OCT) and interpretation of results X X X

IEA.BA.BB Renal angiography function study X X

NAA.BA.BE Renal scan and radioisotope function study X X

SurgeryMOJ.JN.AA Amputation of lower limb X X X

BCD.DB.AE Intravitreal injection of anti-vascular endothelial growth factor (VEGF) X X

IFA.LG.AF;IFA.LH.AF;IFA.LI.AF; IFA.LI.AA

Lower limb vascular intervention (bypass or angioplasty) X X

NAA.KD.AA Renal transplantation X X

BCC.MK.AA Repair of retina (retinal laser photocoagulation) X X

LZZ.JG.AH Ulcer debridement surgery X X X X






















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Clinical interventionType of condition Level of

care

A B C D E F G 1 2 3

Non-surgical interventions MRS.DB.AE Blood glucose management, including self-

monitoring and insulin injections X X X X X X X X X X

LT2.ZY.ZZ Foot ulcer management X X X X X X X X X X

NAA.JC.AF;KMA.JC.AE

Renal replacement therapy X X X

KAZ.AE.AC Periodontal treatment X X X X

HospitalizationPZB.ZZ.ZZ Emergency medical treatment X X X X

III.II Introduction to listing of priority medical devices for cardiovascular diseases and diabetes

The delivery of health care services, today more than ever, has a close relationship with the use of health

technologies. The development and incorporation of these technologies have enabled effective access

to quality care and improved capacity to screen, diagnose, treat, rehabilitate and palliate diseases.

However, deaths occur as a result of lack of accessible, affordable and available technologies, as well as

specialized human resources.

The Priority Medical Devices project, convened by WHO, has the purpose of improving global access to

medical devices. The project aims to produce a list of priority medical devices needed for the management

of high-burden diseases at a given health care level and in a given context (38).

Priority medical devices are health products that respond to priority health interventions. These medical

devices need to be safe, of good quality, effective, appropriate, affordable, accessible and acceptable. They

need to be available to respond to the priority health needs of the setting and should be used safely by the

health care worker or final user. The devices listed in this publication are presented using only generic names

(trademarks or commercial names were not included).

Medical devices that are manufactured, selected, purchased or used need to be assessed and evaluated

locally by authorities to respond to local regulatory requirements, and selected to be affordable by the health

care system. Moreover, the users must be trained for appropriate and safe use of specific medical devices,

whenever this applies. In addition, medical devices must be used by the appropriate user, as most of them are

developed for use by health professionals, but others are intended for use directly by the patient. Depending

on the user, special training or familiarization with the medical device is needed. This also affects directly the

level of care at which some interventions can be performed, depending on the level of specialization of the

staff. Priority medical devices are options that further need to be assessed considering the diverging needs

of countries of differing income levels or other contexts, including appropriate infrastructure, design factors,

and specialized human resources.







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In this document, three different levels are considered. These three levels of health care are referred in the

tables of priority medical devices as “level of care” 1, 2 and 3. They are defined as follows.

Primary health care (level of care 1). This includes (a) essential health care made accessible at a cost that

a country and community can afford, with methods that are practical, scientifically sound and socially

acceptable; and (b) the first level of contact with people acting to improve health in a community, including

through health promotion, disease prevention, screening, rehabilitation, provision of assistive devices and

palliative care (39). This level includes self-testing, self-treatment and personal care; and health posts, health

centres or equivalent health care facilities that have outpatient care.

Secondary health care (level of care 2). This includes ambulatory medical services and commonplace

general hospital care (outpatient and inpatient services). Access is often via referral from primary health care

services. This level generally includes the following medical specialties: general or family medicine, internal

medicine, paediatrics, gynaeco-obstetrics and general surgery (39).

Tertiary health care (level of care 3). This refers to specialized medical and related services of high complexity

and usually high cost technologies that require a specialized health care workforce. These services are used

by those referred from secondary care for diagnosis and treatment not available in primary or secondary

care. Tertiary care is generally only available at specialized, regional or national health care facilities with both

inpatient and outpatient referral centres (39).

Types of medical devices, according to use

Tables will divide the list of priority medical devices in each unit by general or specific use for a disease:

• general medical devices for basic use of the clinical unit to perform a majority of interventions for a big

scope of diseases. Range of specification may vary depending on the level of healh.

• specific medical devices aimed for diagnosis, treatment and rehabilitation interventions of a

specific type of disease. Range of specification may vary depending on the level of health and

specialization of the condition.

• kits or sets, group of instruments, single-use devices and consumables used together for a particular

medical purpose. They are intemised at the end of the intervention table in which they were first

mentioned (or see Annex 5 for a compilation of all kits and sets).

1. Clinical Assessment

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Most premature deaths related to NCDs can be avoided through a combination of early detection and

preventive interventions. The clinical interventions listed in this chapter include simple, affordable tools for

early detection, treatment and risk assessment (Table 10). The aim is to prevent cardiovascular diseases and

diabetes by ensuring equitable access to continuous, standardized, high-quality care for people at high risk.

Table 10. List of clinical assessment interventions

Disease InterventionsLevel of

care

1 2 3

All Anthropometric measurement (height, weight, body mass index, waist and hip circumference) X X X

Assessment of cardiovascular functions X X X

Assessment of respiratory functions X X X

Direct ophthalmoscopy X X X

Measurement of blood pressure X X X

Measurement of body temperature X X X

Test for visual acuity X X X


Electrocardiography test X X

Stroke Neurological assessment X X

Diabetes Examining vibration perception in the feet; motor function and sensory perception testing X X X

Measuring ankle-brachial pressure index X X X

Periodontal examination X X X

Point-of-care blood glucose test X X X

Point-of-care blood ketone test X X X

Table 11 present priority general medical devices that can be used for general assessment of patients for early

diagnostics of various conditions, including cardiovascular diseases and diabetes. Tables 12–14 present the

specific medical devices that are used for disease-specific interventions.

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interventionsGeneral medical devices can be used for various conditions and diseases. They are organized here

by clinical procedure.

Table 11. List of general priority medical devices for clinical assessment interventions

Clinical intervention Level of care

Capital medical devices Consumables, single-use medical devices1 2 3

Anthropometric measurement (height, weight, body mass index, waist and hip circumference)

X X X Scale weight

X X X Body mass index calculator

X X X Measuring tape

Assessment of cardiovascular functions

X X X Stethoscope, binaural ElectrodesElectrolytic gel

X X X Electrocardiography systema

Assessment of respiratory functions

X X X Pulse oximeter Disposable nozzles

X X X Peak flow meter

Direct and indirect ophthalmoscopy

X X X Direct ophthalmoscope Bulbs

X X Indirect ophthalmoscope

Measurement of blood pressure

X X X Blood pressure measurement device

Cuffs (various sizes)

Measurement of body temperature

X X X Thermometera

Test for visual acuity X X X Illiterate vision chart

a. These capital medical devices are described in the table on generic equipment in Annex 4.

1.2 Specific priority medical devices for clinical assessment interventions, by disease

1.2.1 Cardiovascular diseases

Table 12. List of specific priority medical devices for clinical assessment interventions for cardiovascular diseases

Clinical intervention

Level of care Capital medical devices Consumables, single-

use medical devices1 2 3

Electrocardiography test X X Electrocardiography systema (3, 6 or 12

leads, depending on level of care)ElectrodesElectrolytic gel

a. This capital medical device is described in the table on generic equipment in Annex 4.

1.2.2 Stroke

Table 13. List of specific priority medical devices for clinical assessment interventions for stroke

Clinical interventionLevel of care Capital medical devices Consumables, single-


Neurological assessment (visual acuity chart, dermatome chart, Modified Rankin scale, Glasgow coma scale, Functional Assesment Staging (FAST) scale, National Institutes of Health stroke scale)

X X X Examination light Tongue depressor

512 Hz and 128 Hz tuning fork

Reflex hammer

10 g monofilament

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1.2.3 Diabetes

Table 14. List of specific priority medical devices for clinical assessment interventions for diabetes

Clinical interventionLevel of care Capital medical

devices

Consumables, single-use medical devices1 2 3

Examining vibration perception in the feet, motor function and sensory perception testing

X X X 128 Hz tuning fork

Reflex hammer

10 g monofilament

Diabetic foot ulcer risk scales

Measuring ankle-brachial pressure index

X X X Blood pressure measurement device

Cuffs (various sizes)

Doppler ultrasound blood flow measurement system

Periodontal examination1. Gingival inflammation (redness)2. Tooth mobility3. Gingival bleeding4. Depth of gingival pocket1 and 2 as basic exam, and 3 and 4 as clinical standard exam

X X X Examination light Dental mirror Tweezers (for 2)Periodontal probe (for 3 and 4)

Point-of-care blood glucose test X X X Blood glucose metera Single-use sterile lancets for capillary blood collectionBlood glucose test strips

Point-of-care blood ketone test X X X Blood ketone meter Single-use sterile lancets for capillary blood collection Blood ketone test strips


Guidance documents

• WHO list of priority medical devices for cancer management. Geneva: World Health Organization; 2017

(https://www.who.int/publications/i/item/9789241565462).

• Interagency list of priority medical devices for essential interventions for reproductive, maternal,

newborn and child health. Geneva: World Health Organization; 2016 (https://www.who.int/publications/i/

item/9789241565028).

• The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO

Strategic Advisory Group of Experts on In Vitro Diagnostics, 2019

(including the second WHO model list of essential in vitro diagnostics). WHO Technical Report Series

1022 (https://apps.who.int/iris/bitstream/handle/10665/329527/9789241210317-eng.pdf).




https://apps.who.int/iris/bitstream/handle/10665/329527/9789241210317-eng.pdf

2. Emergency care

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Emergency care is an essential part of an effective health system, ensuring timely access to care for all

patients. Well organized emergency care provides timely recognition, resuscitation and referral for severely

ill patients, and definitive care for many others. In many settings, especially where resources are limited,

emergency care is the first point of contact with the health system.

The WHO Emergency Care System Framework defines a series of essential functions for an emergency care

system, ranging from pre-hospital care, to care during transport, to facility-based emergency unit care and

inpatient operative and critical care as needed. Each of the functions described in the WHO Emergency Care

System Framework can be achieved in many ways, depending on available resources, and each is essential to

the delivery of effective emergency care.

Emergency care systems address cardiovascular emergencies such as heart attack and stroke, as well as

metabolic emergencies such as acute complications of diabetes. Emergency care represents a cross-cutting

investment that delivers benefits across other NCDs, injuries, complications of pregnancy and communicable

diseases. It is estimated that over half of deaths in low- and middle-income countries are from conditions that

can be addressed by emergency care (40).

The WHO Essential Resources for Emergency Care describes essential minimum equipment for ambulances

and emergency units at various levels of the health system. Acute cardiovascular diseases, diabetes or stroke

may present with difficulty breathing, shock or altered mental status. Tables 15 and 16 describe emergency

medical devices generally used in such situations. Clinical guidance for front-line emergency providers on

assessment and treatment of acute presentations, such as difficulty breathing, shock, trauma and altered

mental status, can be found in the WHO Basic Emergency Care course (41).

2.1 General priority medical devices for emergency careMedical devices used for emergency care are divided into two categories:

• Basic (B): paramedics, nurse stations, ambulances, stretcher and others, related to level 2 of

health care provision.

• Advanced (A): emergency units in clinics or hospitals, specialized ambulances, related to level 3 of

health care services.

https://www.who.int/publications/i/item/who-emergency-care-system-framework

https://eusem.org/images/Pre0649-Reynolds_Teri.pdf

https://www.who.int/publications/i/item/basic-emergency-care-approach-to-the-acutely-ill-and-injured

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Emer-gency care level

Capital medical devices Consumables, single-use medical devices

2 3

X X Blood glucose metera Glucose meter test strips

X X Control solutions

X X Oxygen cylinder or concentrator with flow meter and masks

Oxygen tubing and connectors

X X Stethoscope, binaural

X X Thermometer If digital, disposable tips

X X Pulse oximeter Probes various sizes

X X Blood pressure measurement device Cuffs (various sizes)

X X Examination light

X Fluid warmer

X Pressure bag for intravenous (IV) infusion

X Automated external defibrillator (AED)

X Laryngoscope Intubation kit

X X Point-of-care haemoglobin/haematocrit testing

X Ophthalmoscope

X Peak flow meter

X X IV infusion flow regulator, manual with dial

X X Intravenous pole

X X Minor surgical set

X Scalpel handle Blades, reusable/single-use

X Intraosseous needle driver, electric or manual

X X Stretchers

X X Patient slide for stretcher transfers

X X Clock

X X Surgery suction systema

Syringes, various sizes

X X Needles (various gauges and lengths; safety single-use)

X X Oral medication supplies (e.g. cups, droppers)

X X Cotton wool

X X Sutures, poliglecaprone

X X Vaseline or paraffin gauze

X X Tongue depressors

X X Finger-stick lancets

X X Elastic bandages

X X Suction catheters

X X Yankauer or other stiff suction tip

X X Nasal prongs (adult, paediatric and neonatal sizes)

X X Oral airways kit

X X Nasal airways

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2 3

X X Bag-valve-mask (adult, paediatric and neonatal)

X X Metered-dose inhaler spacer

X X Ethanol 70% solution

X Rapid infusion catheter

X Nasogastric tubes

X Positive end expiratory pressure (PEEP) valve for bag-valve-masks

X Endotracheal tubes

X X Urine dipstick

X X Urine pregnancy test

X X HIV rapid testing kits

X X Chlorhexidine 5% solution

X X Povidone-iodine solution

X X Aquatabs (or equivalent)

X X Safe final disposal of biological waste

X X Safe final disposal of sharps

X X Registration forms with patient contact information

X X Physical restraints

X X Rescue blankets

X X Patient tags (e.g. bracelets)

X X Adhesive tape

X X Automated external defibrillator (AED), manual external defibrillator

X X Patient physiological monitora Electrodes

X X Sheathed needles

X X Tubing or connectors for needle drainage

X X Fluid collection vessel

X X Fluid collection bag

X X Nasal tampons or equivalent

X X Insulin needles and syringes, various sizes, safety, single-use

X X Heimlich valve and catch bags

X X Maps of local area


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Pre-hospital emergency

careCapital medical devices Consumables, single-use medical

devices

X Ambulance

X Stretcher

X Resuscitation bag

X Oxygen supply system Oxygen mask, patient interface (cannula, mask, non-rebreather) and oxygen tank

X Patient physiological monitora Electrodes, leads, different size cuffs, electrolytic gel

X Aspirator, electric portable Single-use tubing

x Mechanical ventilator (adult, paediatric) Intubation kit

X Infusion pump Infusion set

X Automated external defibrillator (AED), manual external defibrillator

Conductive gel, defibrillator pads

X Stethoscope, binaural Stethoscope covers, alcohol swabs

X Emergency cabinet or container

X Communication system (phone, radio) *


* Consider to add consumables of table 15

Guidance documents

• Jamison DT, Gelband H, Horton S, Jha P, Laxminarayan R, Mock CN et al. Disease control priorities, third

edition: volume 9. Improving health and reducing poverty. Washington (DC): World Bank; 2017 (https://

openknowledge.worldbank.org/handle/10986/28877).

• WHO-ICRC basic emergency care: approach to the acutely ill and injured. World Health Organization

and International Committee of the Red Cross; 2018 (https://www.who.int/emergencycare/publications/

Basic-Emergency-Care/en/).

• Emergency care. Geneva: World Health Organization (https://www.who.int/emergencycare/systems/en/).

• Guidelines for essential trauma care. Geneva: World Health Organization; 2012 (https://www.who.int/

publications-detail/guidelines-for-essential-trauma-care).

https://openknowledge.worldbank.org/handle/10986/28877


https://www.who.int/emergencycare/publications/Basic-Emergency-Care/en/


https://www.who.int/emergencycare/systems/en/

https://www.who.int/publications-detail/guidelines-for-essential-trauma-care

https://www.who.int/publications-detail/guidelines-for-essential-trauma-care

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3. Clinical laboratory

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Clinical laboratory testing plays an essential role in the delivery of health care. The purpose of a laboratory

for clinical diagnostics is to perform accurate testing on patient samples and to analyse and interpret the

results, thereby guiding the diagnosis, treatment, management and monitoring of the patient. The process

for a laboratory diagnostic test comprises the correct identification of the patient, the right test selection

in order to collect the sample of blood or other biological matter from the patient by the nurse, doctor or

phlebotomy technician, and then transfer the sample to the clinical laboratory where the required tests will

be performed by trained laboratory personnel. (42). Some tests are performed manually, and others are done

using automated or semi-automated instrumentation. Therefore, it is crucial that skilled or specially trained

human resources (biomedical laboratory scientists) are available to perform the required tests and provide

clinical advice where needed. The laboratory provides a report of the test results to the referring clinician,

who will then interpret them and decide on the diagnosis and treatment of the patient. Timeliness, accuracy

of results, good-quality management and universal safety are critical elements in the safe functioning of

the clinical laboratory. Quality control tests and external quality assessment schemes should be carried out

regularly as part of laboratory quality assurance (43).

The personnel required depends on the anticipated volume of samples and processes to be handled by

the specific laboratory unit. Depending on the national context and factors, including workforce availability,

different occupations can fulfil the roles that may be required for clinical laboratory testing and pathology.

Prerequisites for that include having the required competencies to perform those roles, and official recognition

in accordance with the scope of practice.

Selection of the equipment for laboratory services depends mainly upon volume and available resources.

The type of equipment selected (for example, automated or semi-automated) should take into account the

facility capacity and the options for purchasing, leasing or renting the equipment and devices, along with the

relevant consumables, accessories and software.

Detailed recommendations for the type of infrastructure required for a clinical laboratory can be found in

ISO 15189:2012 Medical laboratories – requirements for quality and competence, and the WHO list of priority medical devices for cancer management, Chapter 4: Clinical laboratory & pathology (pages 91–96), including

the following procedures of interest:

• pre-analytical procedure: phlebotomy, sample reception and distribution, page 91

• general analytical procedures, pages 92–96.

The diagnosis tests listed in this chapter are those belonging to the clinical laboratory setting (Table

17). Tables 18–22 then present general medical devices that can be used for diagnosis of many diseases,

including cardiovascular diseases and diabetes, and specific medical devices that are used for disease-

specific interventions.

The interventions and tests listed in the tables are, aligned with the WHO model list of essential in vitro diagnostics (34).

https://www.iso.org/standard/56115.html

https://apps.who.int/iris/bitstream/handle/10665/255262/9789241565462-eng.pdf?sequence=1


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care

1 2 3

All Erythrocyte sedimentation rate (ESR) X X X

Haemoglobin (Hb) X X X

Haematocrit (Hct) X X X

Platelet count X X X

White blood cell count, differential leucocyte count X X

Renal function tests (albumin, blood urea nitrogen, creatinine, phosphate, urine chemistry)

X X

Peripheral blood film examination X X

Tests for urinary creatinine, urinary urea, urinary electrolytes (sodium, potassium, chloride) and urinary osmolarity

X X

Complete blood count (automated) X X

Glucose, point-of-care testing X X X

Glucose X X

Serum bicarbonate, blood pH and gases X X

Lipid profile X X

Liver function tests (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, direct and indirect bilirubin, gamma-glutamyl transferase)

X X

Tests for serum triiodothyronine (T3), thyroxine (T4), thyroid-stimulating hormone (TSH)

X X

Electrolytes (sodium, potassium, chloride) X X

Creatinine and albumin to estimate glomerular filtration rate (GFR) and albumin–creatinine ratio (ACR)

X X


Prothrombin time and international normalized ratio (PT/INR) X X

Partial thromboplastin time (PTT), also known as activated partial thromboplastin time (APTT)

X X

Prothrombin time and international normalized ratio (PT/INR), point-of-care testing

X X X

B-type natriuretic peptide (BNP) test, point-of-care testing X X X

B-type natriuretic peptide (BNP) test X X

Tests for cardiac biomarkers (troponin T/I), point-of-care testing X X X

Tests for cardiac biomarkers (troponin T/I) X X

D-dimer, point-of-care testing X X X

D-dimer X X

Stroke Prothrombin time and international normalized ratio (PT/INR), point-of-care testing

X X X

Prothrombin time and international normalized ratio (PT/INR) X X

Cerebrospinal fluid (CSF) bilirubin spectrophotometry X

Diabetes Urinalysis test strips plus microscopy X X

Urinalysis test strips X X X

Haemoglobin A1c (HbA1c) X X

Haemoglobin A1c (HbA1c), point-of-care testing X X X

Urine glucose and ketones X X X

Urine glucose X X X

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3.1 General priority medical devices for clinical laboratory interventions

Table 18. List of general priority medical devices for clinical laboratory interventions


Level of care Capital medical

devicesConsumables, single-use medical devices

1 2 3

Clinical intervention Level of care Capital medical devices Consumables, single-use medical devices

1 2 3

Erythrocyte sedimentation rate (ESR)

X X X Westergren tubes, Wintrobe tubes, racks for holding tubes, stopwatch

Disposable ESR pipettes, venipuncture kit, anticoagulated tubes (sodium citrate for Westergren method and EDTA for Wintrobe method)

X X ESR analyser Reagent kit, calibrators, controls, venipuncture kit, anticoagulated tubes (sodium citrate for Westergren method and EDTA for Wintrobe method)

Haemoglobin (Hb) X X X Sahli’s haemoglobinometer

Hydrochloric acid solution (N/10 HCl), Pasteur pipette, stirring rod, disposable graduated tubes, venipuncture kit, anticoagulated tubes

X X X Colorimeter, racks for test-tubes, autopipette

Drabkin’s solution, test-tubes, pipette tips, venipuncture kit, anticoagulated tubes

Haematocrit (Hct) X X X Clinical chemistry analysera

Reagent kit, calibrators, controls, venipuncture kit

Colorimeter, racks for test-tubes, autopipette

Test-tubes, pipette tips, venipuncture kit, anticoagulated tubes

Platelet count X X X Haemocytometer and microscope, or automated full blood counters

Commercial diluting system

Colorimeter, racks for test-tubes, autopipette

Solution, test-tubes, pipette tips, venipuncture kit, anticoagulated tubes

Peripheral blood film examination or Romanowsky staining

X X Staining rack, dropper, microscope, stopwatch, slide spreader, slide marker, Neubauer chamber (cell counter); or automated haematology analyser

Buffer, methanol (for fixation in case water-based stains are used), dropper, cover slips, pipette tips, test-tubes, venipuncture kit, anticoagulated tubes, reagent kit, calibrators, controls

Automated slide staining system

Venipuncture kit, anticoagulated tubes, reagent kit

Tests for urinary creatinine, urinary urea, urinary electrolytes (sodium, potassium, chloride) and urinary osmolarity

X X Clinical chemistry analysera

Reagent kit, calibrators, controls, venipuncture kitUrine collection kit

Complete blood count, automated

X X Automated haematology analyser


Glucose, point-of-care testing

X X X Point-of-care analyser Reagent strips, lancets, finger puncture kit

Glucose X X Clinical chemistry analysera

Reagent kit, calibrators, controls, venipuncture kit, anticoagulated tubes

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devicesConsumables, single-use medical devices

1 2 3

Serum bicarbonate, blood pH and gases



Lipid profile X X Clinical chemistry analysera


Liver function tests (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, direct and indirect bilirubin, gamma-glutamyl transferase)



Tests for serum triiodothyronine (T3), thyroxine (T4), thyroid-stimulating hormone (TSH)

X X Immunoassay analysera Reagent kit, calibrators, controls, venipuncture kit

Electrolytes (sodium, potassium, chloride)



Creatinine and albumin to estimate glomerular filtration rate (GFR) and albumin–creatinine ratio (ACR)

X X Clinical chemistry analysera (with software to convert serum creatinine to estimate GFR)

Reagent kit, calibrators, controls, venipuncture kitUrine collection kit

a These capital medical devices are described in the table on generic equipment in Annex 4.

The dangers of direct manipulation with bodily fluids in a clinical laboratory setting or in any other clinical unit

are higly important. As in all areas, it is important to have a high-quality washing and sterilization station for

medical devices to ensure quality and safety for patients, doctors, nuerses and technicians.

Table 19. List of general priority medical devices for washing and sterilizing

Priority medical devices for washing and sterilizing

Washer, ultrasonic

Autoclave

Chemical desinfectant

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3.2 Specific priority medical devices for clinical laboratory interventions, by disease


Table 20. List of specific priority medical devices for clinical laboratory interventions for cardiovascular diseases

Clinical interventionLevel of

care Capital medical devices

Consumables, single-use medical devices

1 2 3

Prothrombin time and international normalized ratio (PT/INR), point-of-care testing

X X XPoint-of-care analyser Test-tubes, reagent kit, controls,

anticoagulated tubes, venipuncture kit

X X X Water bath

X X X Stopwatch

X X X Pipette Pipette tips

Prothrombin time and international normalized ratio (PT/INR)

X XCoagulation analyser or incubator (tilt tube method)

Reagent kit, calibrators, controls, reaction cuvettes, anticoagulated tubes, venipuncture kit

Partial thromboplastin time (PTT), also known as activated partial thromboplastin time (APTT)

X X

Coagulation analyser or incubator (tilt tube method)


B-type natriuretic peptide (BNP) test, point-of-care testing

X X XPoint-of-care analyser Reagent kit, controls, venipuncture

kit

B-type natriuretic peptide (BNP) test X X Immunoassay analyser Reagent kit, calibrators, controls,

venipuncture kit


Tests for cardiac biomarkers (troponin T/I), point-of-care testing

X X XPoint-of-care analyser Reagent kit, controls, venipuncture

kit, pipette tips

Tests for cardiac biomarkers (troponin T/I) X X Clinical chemistry

analyseraReagent kit, calibrators, controls, venipuncture kit

D-dimer, point-of-care testing X X X Point-of-care analyser Reagent kit, test card, calibrators, venipuncture kit, pipette tips

D-dimer X X Coagulation analyser Reagent kit, calibrators, controls, venipuncture kit


3.2.2 Stroke

Table 21. List of specific priority medical devices for clinical laboratory interventions for stroke




1 2 3Prothrombin time and international normalized ratio (PT/INR), point-of-care testing

X X XPoint-of-care analyser, water bath, stopwatch, pipette

Test-tubes, reagents, controls, anticoagulated tubes, venipuncture kit, pipette tips

Prothrombin time and international normalized ratio (PT/INR)

X XCoagulation analyser or incubator (tilt tube method)


Cerebrospinal fluid (CSF) bilirubin spectrophotometry X Cerebrospinal fluid puncture kit

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Table 22. List of specific priority medical devices for clinical laboratory interventions for diabetes

Clinical intervention Level of care Capital medical devices

Consumables, single-use medical devices1 2 3

Urinalysis test strips plus microscopy X X

Light microscope, tabletop centrifuge, dipstick analyser

Urine collection kit, slides, cover slips, sterile test-tubes, dipsticks, controls

Haemoglobin A1c (HbA1c) X X Clinical chemistry analyser

Reagents, calibrators, controls, venipuncture kit

Haemoglobin A1c (HbA1c), point-of-care testing X X X Point-of-care analyser Finger puncture kit, controls,

dipsticks

Urine glucose and ketonesX X X

Clinical chemistry analyser

Urine collection kit, dipsticks, colour scale guide, reagents, calibrators, controls, test-tubes

Sets and kits

Venipuncture kit

Tourniquet

Needles, various sizes


Safety needles

IV catheter

IV saline fluid packages

IV lines

Glass and plastic vials

Vacuum blood collection tubes, with or without anticoagulant

Vacuum container hub and needles

Lancets

Alcohol and swabs or prep swabs

Clean gauze squares

Cotton swabs

Roll of strapping

Gloves, non-latex

Waste container for sharps

Reagent kit

Diluent

Distilled water

Reservoir bottle

49

3. C

linic

al la

bo

rato

ry

&HUHEURVSLQDO�µXLG�SXQFWXUH�NLW

Sterile universal specimen bottle, grey

Cerebrospinal fluid manometer

Lumbar puncture set, adult and child

Collection tube, sterile plastic tubes

Skin-cover adhesive strip

Spinal needle

Spinal anaesthesia needle, single-use


Hypodermic needles: 25G, 23G, 21G

Gauze strip, antimicrobial

Antiseptic skin cleansing agent

Skin marker pen

Urine collection kit

Urine collection device (graduated cylinder, specimen cup)

Urine dipsticks

Scale

Sample tubes

Funnel

Guidance documents

• The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO

Strategic Advisory Group of Experts on In Vitro Diagnostics, 2019

(including the second WHO model list of essential in vitro diagnostics). WHO Technical Report Series

1022 (https://apps.who.int/iris/bitstream/handle/10665/329527/9789241210317-eng.pdf).

• ISO 15189:2012 Medical laboratories: requirements for quality and competence. International

Organization for Standardization (https://www.iso.org/standard/56115.html).

• WHO list of priority medical devices for cancer management. Geneva: World Health Organization; 2017

(https://www.who.int/medical_devices/publications/priority_med_dev_cancer_management/en/).

• Laboratory Quality Management System: handbook. Geneva: World Health Organization; 2011 (https://

www.who.int/ihr/publications/lqms_en.pdf).

• WHO Prequalification Team: Diagnostics. WHO manual for organizing a national external quality

assessment programme for health laboratories and other testing sites. Geneva: World Health

Organization; 2016 (https://apps.who.int/iris/bitstream/handle/10665/250117/9789241549677-eng.

pdf?sequence=1, accessed 20 May 2020).


https://www.iso.org/standard/56115.html

https://www.who.int/medical_devices/publications/priority_med_dev_cancer_management/en/

https://www.who.int/ihr/publications/lqms_en.pdf




51

4. Other specialized diagnostics

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PR

IMA

RY

(C

L, H

C),

S

EC

ON

DA

RY

(D

H)

AN

D T

ER

TIA

RY

Le

ve

l o

f care

*

SE

CO

ND

AR

Y (

DH

)

AN

D T

ER

TIA

RY

TE

RT

IAR

Y (

SH

)







Clinical laboratory

Clinical assessment





Point of care


General surgery



Intensive care

Hospitaliza-tion

Rehabilitation


Palliative care


care

Rehabilitation

53

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V�

This section includes those diagnostics that are not performed in a clinical laboratory (Chapter 3) or medical

imaging unit (Chapter 5). After ordering the clinical laboratory tests listed, and before ordering a medical

imaging intervention, doctors may request other specialized diagnostics. Medical complications from

cardiovascular diseases and diabetes can also lead to patient referral for more specialized diagnostics, such

as the ones described on this chapter.

Table 23. List of specialized diagnostic interventions

Disease InterventionLevel of

care

1 2 3

Cardiovascular diseases Cardiac exercise stress test device X

Stroke Electroencephalography X

Diabetes Direct or indirect ophthalmoscopy X X

4.1 Specific priority medical devices for clinical assessment interventions by disease


Table 24. List of specific priority medical devices for specialized diagnostics interventions for cardiovascular diseases




Exercise cardiac stress test device

X Stress test treadmill, bicycle ergometera, b

Electrocardiographic systema, b (12 leads) Electrodes, electrolytic gel

Stress exercise monitoring systemb Printer, paper for printer

Patient physiological monitora, b

Automated external defibrillator (AED), manual external defibrillator

Stretcher


b. These capital equipment devices may be integrated into a single unit.

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Table 25. List of specific priority medical devices for specialized diagnostics interventions for stroke



devices Consumables, single-use medical devices1 2 3

Electroence- phalography

X Electroencephalo-graph (EEG) unit

Electrolytic gel

Reusable spider-type electrode, silver/silver chloride

Reusable electrode-type ear clip, silver or gold

Washable and reusable cable cover

Electro-cap with positioned electrodes according to the International 10-20 system

Original templates (baby, children, adult), allowing complete placement in the skull with 13 or 19 locations for the recording electrodes

Abrasive gel

Photo stimulator

Electrodes, teflon lightweight with gold or silver disc, length 1 m or 1.5 m

Electrodes, high cupula reusable, gold disc with con-nectors at 90 degrees

Electrodes, disposable, adult for patient with sensitivi-ty to silver/silver chloride

Disposable EEG disc electrodes

4.1.3 Diabetes

Table 26. List of specific priority medical devices for specialized diagnostics interventions for diabetes




Direct or indirect ophthalmoscopy

X X X Direct ophthalmoscope Bulbs

X X Indirect ophthalmoscope

55

5. Medical imaging

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PR

IMA

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(C

L, H

C),

S

EC

ON

DA

RY

(D

H)

AN

D T

ER

TIA

RY

Le

ve

l o

f care

*

SE

CO

ND

AR

Y (

DH

)

AN

D T

ER

TIA

RY

TE

RT

IAR

Y (

SH

)







Clinical laboratory

Clinical assessment





Point of care


General surgery



Intensive care

Hospitaliza-tion

Rehabilitation


Palliative care


care

Rehabilitation

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Medical imaging encompasses different imaging modalities and processes to image the human body for

diagnostic and treatment purposes and therefore plays an important role in initiatives to improve public

health for all population groups. The complexity of infrastructure, equipment and human resources for

medical imaging services should be consistent with the capabilities of the health care level in which they are

placed (primary, secondary or tertiary).

Medical imaging devices have very specific infrastructure requirements related to safety and the physical

resources they need to function properly, for example, building requirements for radiation protection

and magnetic safety, three-phase electric power supplies, and correct viewing conditions. Detailed

recommendations on the type of infrastructure required for a medical imaging unit can be found in the WHO list of priority medical devices for cancer management.

The use of the following devices in coordination with defined, evidence-based, clinical procedures and

protocols is important to achieve the best patient outcomes and to use equipment efficiently and effectively.

Existing imaging referral guidelines can be used to enhance appropriateness of referral. The minimum

technical equipment required to respond to the clinical needs are described in the tables, but detailed

technical specifications should be developed according to local needs. Compliance with the Digital Imaging

and Communications in Medicine (DICOM) standard is required when developing a functional network of

medical imaging devices, along with visualization devices and printers as needed. Digital information can

be used in teleradiology applications, and this should be clear in the specification for the particular service

or unit. It is important to note that besides the capital expenses of the building, room infrastructure and

equipment, the expense of DICOM and other information technology (IT) licences, plus the expected cost of

maintaining and updating the licence, should be considered when setting up a medical imaging unit.

A coordinated team of health care professionals (for example, radiographers, radiologists, nuclear medicine

specialists, ultrasonographers and technologists) is essential to the process of producing and interpreting

diagnostic images. Medical physicists have an important role in the optimization of the studies and in the

development of quality assurance, dosimetry and radiation protection programmes that ensure safe and

effective medical imaging. Additionally, biomedical engineers are needed for the technical management

of equipment, and IT specialists are needed to establish and maintain teleradiology systems. Guidance on

education and training in radiation protection of health professionals is available elsewhere (44–46). Depending

on national context, including workforce availability and models, different occupations can fulfil the roles that

may be required for medical imaging. Prerequisites for that include having the required competencies to

perform those roles, and official recognition in accordance with the scope of practice.

Detailed recommendations for the type of infrastructure required for a medical imaging unit can be found in

the WHO list of priority medical devices for cancer management.

Because of the detailed specifications of each item of imaging equipment, this chapter is structured differently

from the rest. After listing the medical imaging procedures (Table 27), the following tables (Tables 28–35) give

a thorough description of the main imaging capital equipment, such as X-rays, ultrasound scans, computer

tomography scans and magnetic resonance images. Tables 36–38 then list specific imaging interventions for

each disease, and the extra equipment or consumables needed for that purpose.

https://apps.who.int/iris/bitstream/handle/10665/255262/9789241565462-eng.pdf;jsessionid=F2990F5FBC76FA01806B20C90374BDC3?sequence=1



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Disease Interventions Level of care

1 2 3

All Ultrasound scan X

X-ray imaging X X

Fluoroscopic imaging X

Computed tomography (CT) scan X X

Magnetic resonance imaging (MRI) X


Positron emission tomography (PET) of myocardium X

Stress and rest test (SPECT) X

Transthoracic echocardiography, stress and rest, with or without contrast

X

Transoesophageal echocardiography X

X-ray imaging (cardiac and peripheral angiography) X

Digital subtraction angiography (DSA) X

Coronary angioplasty with or without stenting X

Percutaneous balloon valvuloplasty (pulmonary, mitral and aortic) X

Peripheral angioplasty with or without stenting X

Stroke Doppler imaging of extracranial vessels X X

Doppler imaging of intracranial vessels X

Optical coherence tomography X X

Eye and orbit ultrasound

Fluorescein angiography or angioscopy of posterior chamber of eye X

Dilatation with insertion of stent or prosthesis of artery of head and neck

X

Endovascular coiling X

Endovascular extraction of obstruction from head and neck vessel (e.g. thrombectomy)

X

Percutaneous angioplasty of carotid artery, extracranial

Diabetes Doppler ultrasonography of the lower extremity arteries X X

Fluorescein angiography X

Fundus photography with non-mydriatic camera and interpretation of results (locally or remotely)

X

Optical coherence tomography (OCT) and interpretation of results X

Renal angiography function study X

Renal scan and radioisotope function study X

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5.1 General priority medical devices for medical imaging interventionsTable 28 presents general devices that should be integral to medical imaging facilities and can be used for

various diseases, including cardiovascular diseases and diabetes.

Table 28. List of general medical devices for ultrasound medical imaging

Imaging techniques

Medical device category Capital medical devices Consumables, single-

use medical devices

For ultrasound technique

Medical equipment Ultrasound scannera with convex probesMiddle-frequency (3–5 MHz) and linear, high-frequency (10–12 MHz) probesColour Doppler probe (optional)

Gel

Consumable for dry printer

Disposable probe drapes

Antimicrobial solution to disinfect probes

Medical furniture Patient examination couch

Positioning aids

Quality control equipment

Quality control test objects and software, ultrasound

For contrast media injection procedure

Medical equipment Contrast media injectora Injection syringes with accessories

Emergency carta

Surgery suction systema

Patient physiological monitora

Medical furniture Mobile infusion pole

Warming cabinet for contrast media

Software Software systems Workstation with storage capacity

Radiology information system

Picture archiving and communication system (PACS)

Dry printera Ink cartridgePaper

Digital storage media Data storage device (CD, DVD, memory stick)


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etes Table 29. List of general medical devices for X-ray radiography medical imaging (levels of care 2 and 3)

Imaging techniques

Medical device category


For basic X-ray radiography technique

Medical equipment General-purpose X-ray system, digital

X-ray tube, radiography


Workstation with storage capacity

Data storage device (CD, DVD, memory stick)

General radiation protection devices

Radiation shielding apron

Radiation shielding gloves

Thyroid shielding

Gonad shielding

Breast shielding

Personal dosimetry equipment

Dosimeter

Software system, electronic dosimeter

Quality control devices

Quality control test objects and software, X-ray


Table 30. Medical devices for general X-ray radiography medical imaging (only for interventions at level of care 2 and 3)

Imaging techniques


use medical devices

Interventional fluoroscopy

Medical equipment for fluoroscopy

X-ray system (C-arm), analogue/digital

X-ray tube, fluoroscopy


Storage media, digital Data storage device (CD, DVD, memory stick)

Workstation with storage capacity

Radiation protection devices


Radiation shielding goggles


Thyroid shielding

Gonad shielding

Breast shielding


DosimeterSoftware system, electronic dosimeter


Quality control test objects and software, X-ray fluorography



Emergency carta




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Table 31. List of general medical devices for angioscopy and angiography

Imaging techniques



Angioscopy and angiography

Medical equipment for angiography

X-ray angiography unit X-ray tube, angiography




Thyroid shielding

Gonad shielding

Breast shielding (optional)

Radiation protection devices for angiography

Radiation shielding screen, ceiling suspended

Radiation shielding curtains, patient table mounted

Radiation shielding screen, mobile

Radiation shielding goggles


Dosimeter



Quality control test objects and software Fluoroscopic X-ray system (C-arm)X-ray angiography



Emergency carta









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etes Table 32. List of general medical devices for CT

Imaging techniques


use medical devices

For computed tomography (CT) technique

Medical equipment Computed tomography systema (slice configuration according to level of care)

X-ray tube, scanner




Thyroid shielding

Gonad shielding

Breast shielding (optional)


Dosimeter



Quality control test objects and software, CT



Emergency carta



Medical furniture Mobile infusion pole

Warming cabinet for contrast media

Software systems Workstation with storage capacity






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Table 33. List of general medical devices for SPECT nuclear medical imaging

Imaging techniques


use medical devices

For low- and medium-energy technique

Medical equipment Gamma camera with SPECT capabilities

Collimators and carts

Laboratory equipment High-performance liquid chromatography scanner

Tc-99m, gallium-68 radionuclide generator (if prepared on site)

Thin layer chromatography scanner

Nuclear medicine radiation protection devices

Hot cell, low–medium energy radiation


Vial radiation shield

Shielding container

Shielding blocks

Shielded storage bins

Radiation safety instruments

Forceps

Needle sheath holder

Tongs

Trays


Quality control test objects and software, SPECT

Dose calibrator

Radiation survey, monitoring

Radiation survey meter, Geiger-Müller counter

Radiation survey meter, area monitor

Personal dosimetry Dosimeter


For preparing and dispensing radiopharmaceuticals

Medical equipment Stethoscope, binaural

Blood pressure measurement monitor

Infusion pump Infusion pump administration set

Tourniquet

Medical furniture Biosafety cabinet, positive pressure

Negative pressure fume hood

Refrigerator

Hot plate with stirrer

Water bath

Solutions and reagents for radiopharmaceutical components

Labelling kits (MDP, MAA, pyrophosphate, MIBI, MAG3, DMSA, nanocolloids, etc.)

Distilled water

Saline solution

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etes Imaging

techniquesMedical device category Capital medical devices Consumables, single-

use medical devices

Injection devices Injection set

Radiation decontamination spill kit


Syringe shield

L-shield

Shielding container

Radioactive waste receptacle







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Table 34. List of general medical devices for general PET nuclear medical imaging

Imaging techniques



For high-energy technique

Medical equipment PET, computed tomography (CT) system

Nuclear medicine radiation protection devices

Hot cell, high-energy radiation


Vial radiation shield

Shielding container

Shielding blocks

Shielded storage bins

Radiation safety instruments

Forceps

Needle sheath holder

Tongs

Trays

Quality control devices Quality control test objects and software, PET

Dose calibrator

Radiation survey monitoring

Radiation survey meter, Geiger-Müller counter

Radiation survey meter, area monitor

Personal dosimetry Dosimeter


For preparing and dispensing radio-pharmaceu-tical

Medical equipment Stethoscope, binaural

Blood pressure measurement monitor

Infusion pump Infusion set

Tourniquet

Injection devices Injection set

Radiation decontamination spill devices


Syringe shield

L-shield

Shielding container

Radioactive waste receptacle







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etes Table 35. List of general medical devices for MRI medical imaging

Imaging techniques



Magnetic resonance imaging (MRI) technique

Medical equipment Magnetic resonance imaging (MRI) systema

Contrast media injectora, MRI safe

Injection set

Patient physiological monitor, MRI safea

Electrodes, MRI safeElectrolytic gel

Anaesthesia system, MRI safea Gas (O2, air, N2O, anaesthetic)

Patient breathing circuit

Soda lime

Oxygen devices, MRI safe Oxygen canisters, MRI safe

Sphygmomanometer, MRI safe

Stethoscope, binaural, MRI safe

Medical instruments Biopsy procedure equipment kit, MRI safe (optional)

Medical furniture Mobile infusion pole, MRI safe

Assistive footstool, MRI safe

Cart, MRI safe

Wheelchair, MRI safe

Stretcher, MRI safe

Quality assurance devices

Quality control test objects and software system, MRI

Others Magnetic metal detector

Foam plugs for ears

For contrast media injection procedure in MRI environment

Medical equipment Contrast media injector, MRI safe Injection set

Emergency cart, MRI safe

Surgery suction systema, MRI safe

Patient physiological monitor, MRI safea

Medical furniture Mobile infusion pole, MRI safe

Warming cabinet (for contrast media), MRI safe







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5.2 Specific priority medical devices for imaging interventions, by disease


Table 36. List of specific priority medical devices for imaging interventions for cardiovascular diseases

Clinical intervention Capital medical devices Consumables, single-use medical devices

Positron emission tomography (PET) of myocardium

See 5.1 (Table 34) General priority medical devices for PET medical imaging

Radiopharmaceutical products

Stress and rest test (SPECT) See 5.1 (Table 33) General priority medical devices for SPECT medical imaging

Radiopharmaceutical products

Exercise cardiac stress test devicea

Emergency cart

Transthoracic echocardiography, stress and rest, with or without contrast

See 5.1 (Table 28) General priority medical devices for ultrasound medical imagingUltrasound scannera with specific cardiac probes

Exercise cardiac stress test devicea

Emergency cart

Transoesophageal echocardiography

Ultrasound scannera with specific transoesophageal probe

Disposable mouthguards

Local anaesthesia set

X-ray imaging (cardiac and peripheral angiography)

See 5.1 (Table 31) General priority medical devices for angiography medical imaging

Coronary artery bypass grafting

Cardiopulmonary bypass system, non-roller type and roller type

See cardiac catheterization laboratory set

Ultrasound scannera

Transoesophageal vascular ultrasound probe

Percutaneous balloon valvuloplasty (pulmonary, mitral and aortic)

Angiography: cath lab system See cath lab set

Coronary angioplasty balloon catheters

Diagnostic and radiofrequency ablation EP catheters

Percutaneous coronary intervention balloon catheters

Balloon valvuloplasty catheters

Electrophysiology catheters

Introducer sheath

Crimpers

Extension tubings

Crimp stoppers

Inflation devices

Peripheral angioplasty, with or without stenting

Angiography: cath lab system See cath lab set


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Cannulas, intravenous, short, sterile (sizes G)

Compress, gauze, sterile and non-sterile

Needles, Luer, sterile (sizes G)

Scalp vein needles, sterile (sizes G)

Syringes (various sizes)

Prongs, nasal, oxygen, non-sterile (various sizes)

Skin cleaning wipe

Tape, medical, roll (various sizes)

Transparent film dressings

Sharps container

Instrument or equipment drape, non-sterile


First aid gauze

Bandage

6SHFL´F�HTXLSPHQW�IRU�KDHPRG\QDPLFV Consumables, single-use medical devices

Resuscitation trolley, equipped

Catheters, cardiac Catheters, intra-aortic balloon

Automated external defibrillator (AED), manual external defibrillator

Arterial and venous sheaths, pressure transducers, tubing

Ultrasound scannera, cardiovascular Electrocardiography electrodesa, reusable/single-use

Haemodynamic monitoring system, multiparametric monitoring system

X-ray contrast medium, injectable (contrast media)

Multipurpose warming cabinet, mobile (contrast media)

Intravenous pole

Oxygen terminal unit

Nitrous oxide/oxygen cylinder (50% nitrous oxide and 50% oxygen)


Radiation protection equipment

Radiation shielding aprons

Suitable suspended or movable screens

Radiation shielding goggles or glasses

Radiation shielding collar

Dosimeter and software system, electronic dosimeter

Radiation warning lights/signs

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Intubation kit

Laryngoscope

Laryngoscope blades, straight, reusable/single-use, sizes 0, 1, 2, 3, 4; and curved, reusable/single-use, sizes 0, 1, 2, 3, 4 (46829 – flexible-end laryngoscope blade)

Laryngoscope batteries

Spare light bulbs

Cannula or single-use tubing

Infusion set

Infusion pump (if available)

Pressure bag for IV infusion

IV infusion flow regulator (manual or with dial)

Intravenous pole

Catheters, various sizes and types

Instrument set for haemodynamics

General-purpose bowl, reusable/single-use (bowl, stainless steel, 250 ml)

Instrument tray

Scalpel handle with blades, reusable/single-use

Artery forceps with oval rings

Dissecting artery forceps, toothed tip

Dissecting artery forceps, toothless tip (blunt)

Iris artery forceps

Towel clamp

Kelly forceps

Mosquito forceps, curved, haemostatic

Needle holder, reusable/single-use

Rake retractor with prong tips

Rake retractor with prong tips, small

Farabeuf retractor

General-purpose surgical scissors, reusable/single-use

Disposables and healing set for haemodynamic procedures

Cutting scissors

Metzenbaum scissors

Syringe-loaded injector, manual, professional (injector syringe, 150 ml)

Blood pressure transducer set

Angiography kit (includes tubing, manifold, stopcocks, and syringes, and other supportive devices: angiography drapes, covers, dressings)

Cardiac/peripheral vascular guidewire, single-use

Multipurpose surgical adhesive tape, non-sterile/sterile

Hypodermic needles, single-use, non-sterile/sterile (needles: 18, 20, 21, 22, 25 gauge)

Adhesive bandage (adhesive patch, transparent, 10 x 12 cm, 8.5 x 10.5 cm, 5 cm x 5.7 cm)

Catheter, peripheral vascular: 14, 16, 18, 20, 22, 24 gauge

Multipurpose surgical adhesive tape, non-sterile/sterile (micropore tape: 2.5 cm and 5 cm)

Anaesthesia breathing circuit, reusable/single-use, non-sterile/sterile (Bain circuit, universal)

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etes Intravenous line/syringe Luer connector, non-sterile/sterile (double male connector, Luer lock)

Electrocardiography electrodesa, reusable/single-use

General-purpose syringe, reusable/single-use: syringe 20 ml



Basic intravenous administration set (disposable sterile kit for puncture site)

Electrosurgical handpiece, reusable/single-use

Intravenous line stopcock (three-way stopcock)

Hypothermia prevention whole body suit (paediatric/adult)

Catheter, peripheral vascular

General-purpose infusion pump, battery-powered/line-powered (infusion pump system, with 150 ml burette)

Infusion controller administration set (micro-drip infusion set)

Infusion controller administration set (macro-drip infusion set)

Examination/treatment gloves, sterile (various sizes)

Surgical sterile gloves, sizes 6, 6Ð, , 7, 7Ð, 8

Blade, scalpel, reusable/single-use

Syringe pump or elastomeric pumps

General-purpose syringe, single-use (Syringe, radiopaque, 50 ml)



Sutures, nylon, calibre 3-0

Sutures, poliglecaprone

Sutures, black silk, braided

Sutures, polypropylene, monofilament

Multipurpose stopper, yellow

Multipurpose stopper, white

Multipurpose surgical adhesive tape, non-sterile/sterile (cloth tape, 2.5 cm)

Multipurpose surgical adhesive tape, non-sterile/sterile (cloth tape, acetate, 50 cm)

Medicine cup, reusable/single-use (polypropylene, 125 ml)

Surgical dressing/drape kit (includes different types of sterile drapes, dressings, covers and towels intended to be used specifically during a surgical procedure)


Clothing for haemodynamic procedures

Operating room gown, reusable/single-use

Surgical shoes

Surgical/examination garment kit (sterile clothes for haemodynamic procedures)

Surgical face mask, reusable/single-use

General-purpose surgical drape, sterile, reusable/single-use

Operating table sheet, reusable/single-use (cover)

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Instruments for airway management and oxygenation

Electronic or mechanical ventilator

Laryngoscope handle, reusable/single-use

Laryngoscope blades, straight, reusable/single-use, sizes 0, 1, 2, 3, 4

Laryngoscope blades, curved, reusable/single-use, sizes 0, 1, 2, 3, 4 (46829 – flexible-end laryngoscope blade)

Oropharyngeal airway, reusable/single-use, sizes 3, 4, 5, 6, 7, 8, 9, 10, 11

Laryngeal airway, reusable/single-use, sizes 1.5, 2, 2.5, 3, 3.5, 4, 5

Basic nasal oxygen cannula

Non-rebreathing/partial rebreathing oxygen face mask

Oxygen cylinder with humidified bottle and regulator

Advanced airway conducts

Local anaesthesia set

Needles and syringes for local anaesthetic


Skin cleaning wipe

Cath lab set

Bandbag, 36 x 40 in., with tape 1

Bowl, guidewire, 2500 cc 1

Bowl, sponge,16 oz., 500 cc 1

Clamps, towel

Cover, setup

Domebag

Drape, femoral angiography

Forcep, Halstead mosquito

Gowns

Introducer, guidewire

Labels, waterproof

Marker, skin

Medicine cups, graduated

Needle holder

Needles, 18G x and 25G x

Scalpel handle with blades

Scissors

Sponges


Table cover

Towels

Tray, organizer

Povidone-Iodine Scrub Solutions

Pressure transducer kit

Access sheath(s)

Guidewire, .035 J-tipped, 180/300 cm lengths

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Catheters, diagnostic, femoral/radial

Interventional

Catheters, interventional, femoral/radial

Workhorse guidewire(s), 183/300 cm length

Specialty guidewire(s)

Angioplasty balloons

Cutting balloon(s)

Drug-eluting stent(s)

Bare metal stent(s)

Covered stent(s)

Balloon indeflator

5.2.2 Stroke

Table 37. List of specific priority medical devices for imaging interventions for stroke


care Capital medical devices Consumables, single-use medical devices

1 2 3Doppler imaging of extracranial vessels X Ultrasound scannera with large

frequency range probes

Doppler imaging of intracranial vessels X Ultrasound scannera with

1.3–4 MHz small footprint

Optical coherence tomography

Optical coherence tomography (OCT) platform

Eye and orbit ultrasound X Ultrasound scannera.

Mode A and BImmersion cups for mode A and B, various sizes.

Fluorescein angiography or angioscopy of posterior chamber of eye

XFluorescein angiograph Sodium fluorescein,

disposable syringes

Dilatation with insertion of stent or prosthesis of artery of head and neck

X Dilatation set

Endovascular coiling X Endovascular embolization set

Endovascular extraction of obstruction from head and neck vessel (e.g. thrombectomy)

X

Endovascular extraction set

Percutaneous angioplasty of carotid artery, extracranial X Percutaneous angioplasty set


73

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ag

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5.2.3 Diabetes

Table 38. List of specific priority medical devices for imaging interventions for diabetes

Clinical interventionLevel of care Capital medical devices Consumables, single-


Doppler echography of the arteries of the lower extremities

X General ultrasound scannera with Doppler probe

Fluorescein angiography X Fluorescein angiograph Sodium fluorescein, disposable syringes

Fundus photography with a non-mydriatic camera

X Non-mydriatic/fundus camera

X Cards for diagnosis of fundus

Optical coherence tomography (OCT)

X Optical coherence tomography (OCT) platform

Renal angiography function study

X See 5.1 (Table 31) General priority medical devices for angiography medical imaging

Renal scan and radioisotope function study

X See 5.1 (Table 33) General priority medical devices for SPECT medical imaging

Radioactive isotopes


Guidance documents

• Education and training in radiological protection for diagnostic and interventional procedures. ICRP

Publication 113. International Commission on Radiological Protection; 2009 (http://www.icrp.org/

publication.asp?id=ICRP%20Publication%20113.

• Guidelines on radiation protection education and training of medical professionals in the European

Union. Radiation Protection No. 175. International Commission on Radiological Protection and

European Commission. European Commission; 2014 (https://ec.europa.eu/energy/sites/ener/

files/documents/175.pdf).

• Radiological protection in fluoroscopically guided procedures performed outside the imaging

department. ICRP Publication 117. International Commission on Radiological Protection; 2010 https://

pubmed.ncbi.nlm.nih.gov/22732420/).

http://www.icrp.org/publication.asp?id=ICRP%20Publication%20113

http://www.icrp.org/publication.asp?id=ICRP%20Publication%20113

https://ec.europa.eu/energy/sites/ener/files/documents/175.pdf


https://pubmed.ncbi.nlm.nih.gov/22732420/

https://pubmed.ncbi.nlm.nih.gov/22732420/

75

6. Surgery

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IAR

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)







Clinical laboratory

Clinical assessment





Point of care


General surgery



Intensive care

Hospitaliza-tion

Rehabilitation


Palliative care


care

Rehabilitation

77

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The objective of a surgical unit is to provide general and specialized surgical care for patients. A central

goal of surgical care is interventional curative treatment. While surgical procedures are intended to save

lives and prevent disability, unsafe procedures or lack of adequately skilled personnel can cause substantial

harm. In 2015, the Lancet Commission on Global Surgery found that 5 billion people do not have access to

safe surgery. The issue was recognized by all Member States in World Health Assembly resolution WHA68.15,

on strengthening emergency and essential surgical care and anaesthesia as a component of universal

health coverage (47). Services provided by a surgical unit must be safe, of high quality, and founded on

guidelines or established standards, as highlighted by the second WHO Global Patient Safety Challenge, Safe

Surgery Saves Lives (48).

Like other hospital units, surgery must be viewed as a part of the larger health system, recognizing that

a surgery unit consists of broad human resource expertise, is linked to other critical health services, and

contributes to wide-ranging service delivery across health disciplines. The surgery unit extends beyond the

operating room and is also linked to pre- and post-operative services involving anaesthesia, pain management

and nursing services. Post-operative nursing care, for example, must be effective in identifying post-

operative complications and recognizing changes or deterioration in patient status, escalating levels of care

appropriately. At its most basic, a surgical unit needs appropriately trained surgical health care professionals,

sufficient physical infrastructure to ensure safe surgery, surgical supplies, and procedures that ensure safety

and quality for both patients and staff.

Detailed recommendations for the type of infrastructure required for a surgical unit can be found in the WHO

list of priority medical devices for cancer management.

The clinical interventions listed in this chapter are those performed in surgery settings (Table 39). The

following tables (Tables 40–43) present general medical devices that can be used for treatment of many

diseases, including cardiovascular diseases and diabetes, and specific medical devices that are used for

disease-specific interventions.

Table 39. List of surgical interventions

Disease InterventionsLevel of care

1 2 3Cardiovascular diseases

Balloon atrial septostomy X

Balloon dilatation for coarctation X

Cardiac pacemaker implantation X

Cardiac resynchronization therapy (CRT), defibrillator implantation X

Coronary artery bypass grafting X

Cardiac electrophysiology and catheter ablation X

Correction of congenital heart disease X

Repair of heart valve X

Right heart cardiac catheterization X

Stroke Skull neurosurgery X

Craniectomy X

Craniotomy X

Extraventricular drain placement X

Endarterectomy of carotid artery, extracranial X

Endovascular embolization or occlusion of head and neck vessels X

Implantation of left atrial appendage device X

Repair of atrial septal defect of heart with graft or prosthesis X

Surgical aneurysm clipping X

Thrombolysis of artery, head and neck (percutaneous transluminal) X

Thrombolysis of intracranial artery (percutaneous transluminal) X



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Disease InterventionsLevel of care

1 2 3Diabetes Amputation of lower limb X X

Intravitreal injection of anti-VEGF X

Lower limb vascular intervention (bypass or angioplasty) X

Renal transplantation X

Repair of retina (retinal laser photocoagulation) X

Ulcer debridement surgery X X

6.1 General priority medical devices for surgical interventions

Table 40. List of general priority medical devices for surgical interventions

Category of medical device

Level of care Capital medical devices Consumables, single-use medical

devices1 2 3

Medical equipment

X X Anaesthesia systema, mobile Anaesthesia breathing circuit, reusable/single-use, non-sterile/sterile (Bain circuit, universal)

Electronic ventilator

Nitrous oxide/oxygen terminal unit (oxygen and nitrous oxide supply)

Breathing circuit bag, reusable/single-use (breathing bag)

Carbon dioxide absorber, reusable/single-use (absorber and soda lime)

Carbon dioxide absorbent (soda lime)

X X Surgery suction systema Suction system tubing (Yankauer suction tube, 270 mm)

Basic suction tip, reusable/single-use (Yankauer suction tips)

Suction system tubing (suction tube, L50 cm, catheter tip, sterile, single-use, sizes G)

Suction system bottle

Suction system canister, bottle holder

Suction system filter, microbial (suction trap to collect fluid specimens)

X X Electrosurgical unit Electrosurgical handpiece, reusable/single-use (electrosurgical pencil, monopolar pen)

Electrosurgical return electrode, reusable/single-use, non-sterile/single-use, sterile

Electrosurgical return electrode, reusableElectrosurgical return electrode, single-use, non-sterile/sterile

Electrosurgical/ultrasonic surgical system generator, Unit for haemostasis by thermocoagulation, Electrocautery system generator, Battery-powered/line-powered

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devices1 2 3

X X General-purpose mechanical infusion pump,battery-powered/line-powered/, reusable/single-use

Basic intravenous administration set

X X Fluoroscopic X-ray system (C-arm), analogue or digital

X X Operating light, double or single

Operating, examination or treatment light handle cover, reusable/single-use

X X Pulse oximeter, line-powered or battery-powered

X X Thermometer, continuous electronic

X X Universal operating table (electrohydraulic, electromechanical, hydraulic)

X X Resuscitation trolley equipped Intubation kit

X X Cardiopulmonary bypass system, non-roller type or roller type

X X Cardiopulmonary bypass system heat exchanger

X Temporary pacemaker

X X Automated external defibrillator (AED)

Pads, contact gel

Medical furniture

X X Stretcher

X X Anaesthetist’s trolley

X X Instrument storage cabinet

X X Instrument table

X X Infusion stand, double hook, on casters

X X Kick bucket

X X Operating room stool

X X Surgical scrub station

X X Utility trolley (dressing trolley, stainless steel, two trays)

X X Emergency trolley, with drawers

X X Laundry/linen trolley

X X Radiographic film view box magazine

X X Bowl/basin stand (stand, single bowl, on casters)

X X Surgical tray stand (Mayo stand)

X X Blanket warmer

X X Cabinet, medicines, double door

X X Wheelchair

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devices1 2 3

Personal protective equipment and clothing

X X Clogs, plastic

X X Bed sheet, reusable/single-use

X X Eye splash shield

X X Examination gloves, non-sterile, single-use

X X Surgical gloves, sterile

X X Shoe covers, non-conductive, sterile/non-sterile

X X Surgical cap, reusable/single-use

X X Operating room gown, reusable/single-use

X X Surgical apron, reusable/single-use (aprons, impermeable)

X X Surgical face mask, reusable/single-use

X X General-purpose surgical drape, sterile, reusable/single-use

X X Patient gown, reusable/single-use

X X Surgical scrub station (medical scrubs for health care workers or similar)

Single-use devices, disposables, medical supplies

X X Anaesthesia breathing circuit, reusable/single-use, non-sterile/sterile (Bain circuit, universal)

X X Gauze roll, non-sterile/sterile

X X Basic endotracheal tube, reusable/single-use

X X Basic intravenous administration set

X X Oxygen administration kit, non-sterile/sterile (mask and tubing for oxygen)

X X Electrocardiography electrodesa reusable/single-use (monitoring electrodes)

X X Nasogastric tubes

X X Operating room laundry bag

X X Donor organ preservation/transport bag

X X Skin-cleaning wipe, non-sterile/sterile

X X Sutures

X X General-purpose syringe, single-use

X X Hypodermic needle, single-use, non-sterile/sterile

X X Multipurpose surgical adhesive tape, non-sterile/sterile (medical tape rolls, various sizes)

X X Non-wearable urine collection bag, non-sterile/sterile

X X Surgical scrub sponge

X X Basic intravenous administration set (intravenous cannulas or catheters)

X X Laryngeal mask airways

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devices1 2 3

X X Oropharyngeal airway

X X Basic endotracheal tube, reusable/single-use

X X Endotracheal tube introducer, reusable/single-use

X X Operating table sheet, reusable/single-use (cover)

X X Bedmat, absorbable

X X Arm/leg tourniquet, reusable/single-use

Waste disposal container

X X Bedpan Sponge bowl, reusable/single-use

X X Emesis bowl, reusable/single-use

Skin marker guide

X X Cardiopulmonary resuscitation kit, including resuscitator bag valve and mask (adult and paediatric)

Sharps container


6.2 Specific priority medical devices for surgical interventions, by disease


The purpose of cardiovascular surgery is to prevent, diagnose, treat, or monitor palliative cardiovascular

disease. Cardiovascular surgery may be open or minimally invasive, and may involve electrophysiology,

endoscopy, laparoscopy, and interventional radiology. Cardiovascular surgery covers multiple procedures

ranging from anatomical restructuring – such as coronary angioplasty or grafting to unblock blood vessels – to

implantation of mechanical products for cardiac resynchronization, for example. Percutaneous interventions

for the coronary and the peripheral vascular system are catheter-based procedures often used to open

partially or fully blocked blood vessels in people with cardiovascular disease. These procedures are done

by a broad spectrum of specialists highly experienced at performing many traditionally invasive complex

procedures, including interventional cardiology, electrophysiology, cardiovascular surgery, interventional

radiology, and vascular surgery. Cardiovascular surgeons are clinical specialists aided by teams composed of

nurses, interventional radiologists, radiographers and radiological technologists, and surgical technologists.

While some cardiovascular surgery can be performed in a general operating theatre, high-risk procedures

must be conducted in a cardiac catheterization laboratory (cath lab). A cath lab is a room with a collection of

medical devices that are used together during specific cardiovascular interventions.

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Capital medical devices


1 2 3

Balloon atrial septostomy

X Angiography: cardiac catheterization laboratory (cath lab) system

See cath lab set

Balloon dilatation for coarctation

X Angiography: cath lab system

See cath lab set

Cardiac pacemaker implantation

X Pacemaker, invasive Double or single chamber pacemaker generator, MRI-compatible or non-compatible

Cable electrode by atrial or ventricular chambers, transvenous introducers

Cable analyser and programmer

Cardiac resynchronization therapy (CRT), defibrillator implantation


Device implantation kit

See cath lab set

Implantable cardioverter defibrillator

CRT (with/without defibrillation) generator

Atrial cable electrode

Right ventricle power and pace cable

Left ventricle cable electrode

Left ventricle access system

Coronary artery bypass grafting

X Cardiopulmonary bypass system, non-roller type or roller type

Ultrasound scannera

Transoesophageal vascular ultrasound probe

See cath lab set

Catheters, coronary angioplasty balloon

Catheters, diagnostic and radiofrequency ablation, electrophysiology

Catheters, percutaneous coronary intervention balloon

Catheters, balloon valvuloplasty

Catheters, electrophysiology

Introducer sheath set

Crimpers

Extension tubings

Crimp stoppers

Inflation devices

Cardiac electrophysiology and catheter ablation

X Cardiac ablation unitEchography system

Diagnostic and radiofrequency ablation Catheters, electrophysiologyIntroducer sheath set

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1 2 3

Correction of congenital heart disease


See cath lab setMetal stent or mesh

Repair of heart valve X Angiography: cath lab system

See cath lab setAnnuloplasty band

Right heart cardiac catheterization


See cath lab set


6.2.2 Stroke

Table 42. List of specific priority medical devices for surgical interventions for stroke




1 2 3Skull neurosurgery X Skull neurosurgery set

Craniectomy X High-speed surgical drill (craniotome)

Heads of various types, tissue guard, lubricant oil, sterilization case, brush, saw blades, drill bits, nitrogen

X Trepanation attachment

Craniotomy X High-speed surgical drill (craniotome)Operating microscopeNeuronavigation equipment for precision clot evacuation

Craniotomy set

Extraventricular drain (EVD) placement

X EVD set EVD close drainage system

Endarterectomy of carotid artery, extracranial

X Endarterectomy set

Endovascular embolization or occlusion of head and neck vessels

X Endovascular embolization set

Implantation of left atrial appendage device

X Implantation of left atrial appendage device set

Repair of atrial septal defect of heart with graft or prosthesis

X Apparatus for cardiopulmonary bypass

Atrial septal set

Surgical aneurysm clipping

X Operating microscope with intraoperative on-table cerebral angiogram

Aneurism setTitanium clips as per the pathological anatomy of the aneurysm (preferable to have the entire set of clips available to have good operative clipping of the aneurysm)

Thrombolysis of artery, head and neck (percutaneous transluminal)

X Thrombolysis set

Thrombolysis of intracranial artery (percutaneous transluminal)

X Thrombolysis set

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Table 43. List of specific priority medical devices for surgical interventions for diabetes



1 2 3

Amputation of lower limb

X X Anaesthesia systema Orthopaedic operative set

Amputation blade Rongeur

Oscillating bone saw or manual saw Suction drain

Tourniquet Clamp

Intravitreal injection of anti-VEGF

x None Prefilled anti-VEGF syringe, single-use

Lower limb vascular intervention surgery (bypass or angioplasty)

x Angiography: cath lab system See cath lab set

Renal transplantation x Anaesthesia systema ClampSurgery set

Repair of retina (retinal laser photocoagulation)

x Slit lamp laser system, camera-based photocoagulation system Contact lens

Ulcer debridement surgery

X x Scalpel handle Dressing set:Forceps, arteryForceps, dressing, standard, 155 mm, straightScissors, Deaver, 140 mm, straight, sharp/bluntDishes, kidneyBlades, reusable/single-use


Skull neurosurgery set

Gouge, Leksell or Leksell-Stille, angulated, wide point, length 229–250 mm

Gouge, Stille-Luer, straight, length 200–230 mm

Gouge, Echlin, wide point, length 230 mm

Gouge, Stille-Luer, curved, length 220–230 mm

Bunnell drill set, manual

Cone driller, 12 mm x 22.9 cm

Cone driller, for skull, children

Protective clamp, with an extreme hole, cross-strips, with zipper, length 150–160 mm

Dandy clamp

Love-Gruenwald clamp, straight, 3 x 10 mm bit, length 180 mm

Kerrison-type clamp

Standard clamp, straight, with 2 x 3 teeth, length 140–150 mm

Potts-Smith clamp, straight, without teeth, with tungsten carbide inserts, length 240–250 mm

Gerald clamp, straight, with teeth, length 170–180 mm

Crile clamp, curved, with 1 x 2 teeth, length 140 mm

DeVilbiss clamp, cranial, length 205–210 mm

Adson clamp, in bayonet, without teeth, length 18.5 cm

Ferris-Smith clamp, straight, 4 mm bit, length 120 mm

Halsey needle holder, straight, with central slot, with tungsten carbide inserts, length 130–135 mm

Crile-Wood needle holder, straight, stretched jaw, length 145–150 mm

Saw, Gigli or Olivecrona, length 500–510 mm, with two grip handles in the form of a T

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Craniotomy setInstrument tray, stainless steel


Penfield dissector

Handle for bistoury

Backhaus towel clamp, length 130–140 mm

Adson clamp, with 1 x 2 teeth, length 110–125 mm

Foerster or Foerster-Ballenger clamp, straight, crossed, length 180 to 200 mm

Allis clamp, with 4 x 5 teeth, length 150–155 mm

Adson clamp, without teeth, length 110–120 mm

Needle holder

Senn-Mueller separator, round or sharpened point, length 15 cm

Volkmann separator

Farabeuf separator, set of 2, length 150–155 mm

Weitlaner separator, with self-retaining mechanism

Taylor scissors, length 17 cm

Metzenbaum scissors, straight, with tungsten carbide inserts, length 180–185 mm

Mayo scissors, straight, length 150–155 mm

Mayo-Stille scissors, curved, with tungsten carbide inserts, length 145–155 mm

Hudson drill set, 9, 14, 16, 22 mm

McKenzie drill, 13 mm x 9.8 cm

Frazier cannula

Cobb knife, number

Dandy nerve hook

Sachs hook





Bunnell drill set



Dandy nerve clamp

Ferris-Smith-Kerrison clamp, angle at 40 degrees, 5 mm bit, length 180 mm

Kerrison-type clamp







Crile-Wood needle holder, straight, stretched jaw, with tungsten carbide inserts, length 145–150 mm


Scissors for wire, universal, length 12 cm

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Metal ruler (min 15cm)


Operating scissors

Stitch scissors, standard

Forceps

Bone/cartilage clamp

Rongeur

Bone mallet

Osteotome

Retractor

Suction tube

Surgery set


Scissors

Forceps, dressing

Forceps, tissue

Needle holder

Forceps, haemostatic

Forceps, towel clamp

Forceps, sponge

Retractor

Forceps, tissue

Dressing set

Forceps, artery, Kocher, 140 mm, straight

Forceps, dressing, standard, 155 mm, straight

Scissors, Deaver, 140 mm, straight, sharp/blunt

Dishes, kidney type

Guidance documents

• Resolution WHA68.15. Strengthening emergency and essential surgical care and anaesthesia as a

component of universal health coverage. In: Sixty-eighth World Health Assembly, May 2015. Geneva:

World Health Organization; 2015 (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_R15-en.pdf).

• Safe surgery: why safe surgery is important. Geneva: World Health Organization (https://www.who.int/

teams/integrated-health-services/patient-safety/research/safe-surgery).

http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_R15-en.pdf

https://www.who.int/teams/integrated-health-services/patient-safety/research/safe-surgery


87

7. Non-surgical interventions

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(C

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H)

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SE

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ND

AR

Y (

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)

AN

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TE

RT

IAR

Y (

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Clinical laboratory

Clinical assessment





Point of care


General surgery



Intensive care

Hospitaliza-tion

Rehabilitation


Palliative care


care

Rehabilitation

89

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ntio

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Once a patient is diagnosed, doctors will prescribe an appropriate treatment. In many cases, that treatment

will include medications, surgical interventions, or non-surgical interventions, or a combination of the three.

Non-surgical interventions are those that are not necessarily performed under a surgical unit; some can

even be done at home. Table 44 presents some priority non-surgical interventions for stroke and diabetes.

The following tables (45 and 46) list the medical devices needed for such interventions. Rehabilitation and

palliative care interventions will be detailed in Chapters 10 and 11.

Table 44. List of priority non-surgical interventions

Disease Interventions Level of care

1 2 3

Stroke Intermittent pneumatic compression X X

Percutaneous endoscopic gastrostomy (PEG) X X

Diabetes Blood glucose management, including self-monitoring and insulin injections X X X

Foot ulcer management X X X

Haemodialysis X X

Peritoneal dialysis X X X

Periodontal treatment X X X

7.1 Specific priority medical devices for non-surgical interventions, by disease

7.1.1 Stroke

Table 45. List of specific priority medical devices for non-surgical interventions for stroke




1 2 3Intermittent pneumatic compression

X X Circulatory assistance unit for peripheral compression

Bed support

Clamping devices, hand, foot, calf, thigh, abdomen, hip

Multipurpose devices, hoses

Percutaneous endoscopic gastrostomy (PEG)

X X Endoscopy unit

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Table 46. List of specific priority medical devices for non-surgical interventions for diabetes


Level of care



1 2 3

Blood glucose management, including self-monitoring and insulin injections

X X X Refrigerator SyringeNeedleVials (of insulin)SwabsLancetStrips

Blood glucose metera

Foot ulcer management

X X X Therapeutic footwear Forceps, artery

Orthoses (lower limb)



Dishes, kidney

Haemodialysis X X Haemodialysis machine Reverse osmosis water treatment equipmentHaemodialysis furnitureSpecialized nurse workstation

Haemodialysis set

Swabs

Peritoneal dialysis X X X Peritoneal dialysis machine Sterile, disposable, PVC multiconnector system for connecting up to four bags of peritoneal dialysis solution; system compatible with brand and model of the equipmentBags of dialysis solution of different concentrations and connectors, compatible with the brand and model to the equipment

Periodontal treatment X X X Mechanical tooth-cleaning kit for scaling

Plaque control kit (toothbrush, floss, mouth rinse)

This capital medical device is described in the table on generic equipment in Annex 4.

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Reverse osmosis water treatment equipment

Hydropneumatics system

Activated carbon tank

Softener tank with brine tank

Reverse osmosis water tank

Reservoir tank of treated water

Recirculation pumps

Ultraviolet (UV) light lamp

Microfilter

Remote alarm system

Pallet to stow goods

Iodine-free pelleted salt sacks

Disinfectant

Input filter of 1.5 microns

Haemodialysis furniture

Haemodialysis chair with Trendelenburg position

Intravenous pole

Oxygen wall outlet

Air wall outlet with surgery suction systema

Dialysate conductivity monitor

Sharps container

Container for hazardous medical waste

Diagnostic set or system (includes otoscope, ophthalmoscope and laryngoscope)

Automated, non-invasive blood pressure device, with proper-sized upper arm cuff

This capital medical device is described in the table on generic equipment in Annex 4.

Haemodialysis set

Solutions for haemodialysis: with variable concentrations of calcium and potassium, according to user requirements, sodium bicarbonate for manual or automatic preparation

Arterial and venous lines with pressure transducer protector, disposable and adaptable or integrated to arterial and venous lines (neonatal, paediatric, adult)

Arteriovenous fistula puncture needles

Filter for haemodialysis or haemodialyser

Disinfectant and descaling agent

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8. Hospitalization

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TE

RT

IAR

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Clinical laboratory

Clinical assessment





Point of care


General surgery



Intensive care

Hospitaliza-tion

Rehabilitation


Palliative care


care

Rehabilitation

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osp

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A patient can be admitted into a hospital for multiple reasons, including scheduled tests, procedures, or

surgery; emergency medical treatment; administration of medication; or to stabilize or monitor an existing

condition (49). The inpatient unit is essential and is the most interconnected to all the other hospital units,

as it provides a continuum of medical or nursing care plus other hospital services. When admitted, a patient

should have a bed assigned either in a private or in a common room with all the required medical equipment

and care (including medicines, rehabilitation, treatment and diet), depending on each patient’s needs. A

hospitalization unit should have a nurse station that can store all the patient’s information and needed

instrumentation. There should be at least a 1:8 nurse-to-patient ratio.

In most high-income countries, hospitals manage to cover the needs of the inpatient unit. However, around

the world, most hospitals are saturated, patients will not always have access to a personal bed, nurses and

physicians are overwhelmed, the rehabilitation workforce is not available, and not all the needed medicines,

medical and rehabilitation equipment are available. Patient safety is a serious global public health concern;

estimates show that one in every 10 patients is harmed while receiving medical care (50).

The table 47 lists priority interventions taking place under a hospitalization setting for the three diseases. The

following tables (48 -51) detail the medical devices needed for said interventions.

Table 47. List of hospitalization interventions


care

1 2 3

All Inpatient admission X X

Clinical and paraclinical monitoring (scheduled tests) X X

Medical treatment and wound care X X

Administration of medication (administration of oral and parenteral treatment)

X X


Thrombolysis X

Echo Doppler X X

Intra-aortic counterpulsation X

Stroke Thrombolysis X X

Kinesiotherapy X X

Diabetes Emergency medical treatment X X

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Table 48. List of general priority medical devices for hospitalization interventions


Level of care Capital equipment Consumables, single-use

medical devices1 2 3

Inpatient admission X X StretcherHospital bedMattress for bedBedrailWheelchairWaste disposal unitsResuscitation trolleyNurses’ central monitoring station (specified bellow)Sterilization unit

Patient record chartBed sheetsNeedlesInfusion set

Clinical and paraclinical monitoring (scheduled tests)

X X Blood pressure measurement monitorElectrocardiography systema or patient physiological monitora

ECG electrodesElectrolytic gelDisposable oxygen saturation with non-invasive haemoglobin sensor and end tidal carbon dioxide sensorDisposable sample lines Cuffs, blood pressure

Medical treatment and wound care

X X MedicinesDressing set

Administration of medication (oral and parenteral treatment)

X X Intravenous pole Infusion pump

Infusion set


Nurses’ central monitoring station

Crash cart with automated external defibrillator (AED) and monitoring

Electrocardiography systema

Wheelchair

Electronic scale

Automated, non-invasive blood pressure device

Stethoscope, binaural


Flexible LED examination lamp on casters

Thermometer

Pulse oximeter

Blood glucose metera, portable

Medication refrigerator

Surgery suction systema, toraxic

Whole blood coagulation analyser

Haematology analyser

Red bag container for hazardous medical waste

Pasteur table, stainless steel

Point-of-care analyser


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8.2 Specific priority medical devices for hospitalization interventions, by disease


Table 49. List of specific priority medical devices for hospitalization interventions for cardiovascular diseases




Thrombolysis X X-ray system, mobile Catheters, interventionalThrombolytic medicationContrast media

Echo Doppler X X Ultrasound scannera Ultrasound gelUltrasound probes

Intra-aortic counterpulsation

X Intra-aortic balloon pump unit

Catheters, interventional


8.2.2 Stroke

Table 50. List of specific priority medical devices for hospitalization interventions for stroke




1 2 3Thrombolysis X X X-ray system, mobile Catheter, interventional

Thrombolytic medicationContrast media

Kinesiotherapy X X Bands, resistance

8.2.3 Diabetes

Table 51. List of specific priority medical devices for hospitalization interventions for diabetes



deviceConsumables, single-use medical devices

1 2 3

Emergency medical treatment (insulin management)

X X Intravenous pole Infusion pump

NeedlesInsulinInfusion set

Guidance documents

• WHO, Medical devices by health care facility, (https://www.who.int/activities/prioritizing-medical-devices).

https://www.who.int/activities/prioritizing-medical-devices

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9. Intensive care units

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Clinical assessment





Point of care


General surgery



Intensive care

Hospitaliza-tion

Rehabilitation


Palliative care


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An intensive care unit (ICU) aims to support patients who are at immediate risk of undergoing or developing

vital organ failure. It can be understood as a hospitalization unit that includes intensive and specialized medical

and nursing care. ICUs offer medical staff who are specialized in caring for critically ill patients. ICUs have

the capacity to sustain physiological organ support and are equipped with advanced patient physiological

monitors. They are found in high-income countries but are becoming an important part of health structures

in low- and middle-income countries as well.

The rooms of ICU units should be large enough to deal with emergencies, and it should be possible to

easily move beds and equipment (for example, resuscitation trolleys, oxygen devices or imaging modalities).

Subsequently, doors should be wide enough to avoid blockages and the whole unit should benefit from

proper ventilation, cooling and heating. Moreover, ICUs need to be connected to oxygen, pressurized air and

vacuum outlets, and a proper electricity supply, and need to be secured with a continuous emergency power

supply system. Spacious working areas, offices for medical staff, and staff rest areas are highly recommended

to increase the efficiency of the department.

The extent, as well as the capacity, of ICUs in hospitals can differ according to the level of specialization.

Moreover, some hospitals feature an ICU to deal with specific types of patients or medical requirements.

The ICU specialized in dealing with cardiovascular diseases, for example, can be termed a coronary care unit

(CCU). CCUs are specifically designed and equipped to deal with life-threatening cardiovascular conditions.

Most patients will be transferred to a ward when intensive care is no longer needed.

Some hospitals feature a stroke unit or a neurology intensive unit, which is entirely devoted to care for

patients with stroke and its complications. Stroke units and neurology intensive units are staffed with highly

trained medical personnel, educated in specialized stroke care.

The clinical interventions listed in this chapter are those applicable to the ICU (Table 52). The extent of

possible interventions depends on the level and degree of specialization of the ICU (for example, whether a

CCU or stroke unit is present).

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care

1 2 3

All ICU admission X

Intubation X X

Continuous infusion and application of supportive drugs X X

Continuous multiparametric cardiac monitoring with non-invasive or invasive blood pressure monitoring

X X

Blood gas analysis X X

Ultrasound scan X X X

Mechanical ventilation X

Oxygen therapy X X

Imaging of the chest X X

Point-of-care glucose test X X X

Suction of fluids X X

Defibrillation and external pacemaker X X X

Resuscitation X X X


Angiography X

Temporary transvenous pacing X

Intra-aortic balloon pump X

Stroke Intracranial pressure monitoring X

Near-infrared spectroscopy monitor X

Diabetes Dialysis X X X

Haemodialysis X X

Renal replacement therapy X

Continuous glucose monitoring X X

9.1 General priority medical devices for the intensive care unitTable 53 presents general medical devices that are used for interventions in ICUs. The extent and availability

of medical devices depend on the level of the ICU and whether a specialized unit (for example, CCU or

stroke unit) is present.

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Table 53. List of general priority medical devices for intensive care unit interventions


Level of care Capital equipment Consumables, single-


ICU admission X StretcherHospital bedPressure relief mattress for bedBedrailWheelchairWaste disposal unitsResuscitation trolleyNurse’s stationSterilization unitAutoclave, washer, disinfectors RespirometerBlood warmerVascular duplex scannerPneumatic compression machineContinuous positive airway pressure (CPAP) machineApheresis machine

Chart, patient recordBed sheetsNeedlesInfusion setChemical supplies for autoclave/washer

Intubation X X Laryngoscope Intubation kit

Continuous infusion and application of supportive drugs

X X Infusion pump, precise graduationInfusion stand, double hook, on castersPatient-controlled analgesia pumpsRapid infusion device

Infusion set

Continuous multiparametric monitoring with non-invasive/invasive blood pressure monitoring

X X Patient physiological monitora

(ECG five channel, NIBP, EEG headset SpO

2 and etCO

2, temperature, cardiac

output, non-invasive haemoglobin, SpHb, CVP, MAP)

ECG electrodesEEG headsetElectrolytic gel Disposable oxygen saturation sensorCuffs, blood pressure

Blood gas analysis X X Blood gas analyser, automated or semi-automated Electrolyte analyser

ReagentsCalibration fluids

Ultrasound scan X X X Ultrasound scannera Ultrasound gelUltrasound probes

Mechanical ventilation X Ventilator, different interfaces; should include continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BPAP), etCO

2

monitor

Ventilator set

Oxygen therapy X X Oxygen devices Oxygen masks and tubes

Imaging of the chest X X X-ray system, mobile Film or digital detectorProtective equipment

Point-of-care blood glucose test

X X X Blood glucose metera Glucometer stripsSpare batteries for the glucometer

Suction of fluids X X Surgery suction systema Surgery suction system seta

Defibrillation, external pacemaker and resuscitation

X X X Automated external defibrillator (AED) Defibrillator electrodesElectrolytic gel Spare battery

X X X Resuscitation trolley, equippedCardiopulmonary resuscitation kit, including resuscitator bag valve and mask Emergency trolley, with drawersUtility trolley (dressing trolley, stainless steel, two trays)StretcherLaundry/linen trolleyInstrument tableInstrument storage cabinetKick bucket

Resuscitator bag valveResuscitator maskStretcher linenTearproof bags


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Expiratory valve assemblies

Flow sensors

Non-invasive ventilation (NIV) mask

Ventilator tubes

Surgery suction system set

Suction system tubing (Yankauer suction tube, 270 mm)






9.2 Specific priority medical devices for monitoring and intensive care unit, by disease


Cardiovascular monitoring after a cardiovascular event is carried out in the cardiovascular intensive care

unit. The length of time in the unit will depend on the particular heart problem that the patient has. The

professionals that work in the unit will have had advanced training on how to take care of patients with vascular

problems and special training on all of the equipment available for treating cardiovascular emergencies.

The cardiovascular intensive care unit is specialized in the care of patients with cardiovascular conditions

that require continuous monitoring. Table 54 details the medical devices listed for each intensive care unit

intervention for cardiovascular diseases.

Table 54. List of specific priority medical devices for intensive care unit interventions for cardiovascular diseases




Angiography X Angiography system Angiography equipment (cushions, protective equipment)

Temporary transvenous pacing

X Temporary external transvenous pacing generator

Central venous access kitPacing lead

Intra-aortic balloon pump

X Angiography: cath lab systemBalloon pump

Cath lab set

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9.2.2 Stroke

Table 55 details the medical devices listed for each intensive care unit intervention for stroke.

Table 55. List of specific priority medical devices for intensive care unit interventions for stroke




Intracranial pressure monitoring

X Intracranial pressure monitor Catheter (filter, needle with luer lock, case and cap)

Near-infrared spectroscopy

X Infrared spectrometer system Headband

9.2.3 Diabetes

Table 56 details the medical devices listed for each intensive care unit intervention for diabetes.

Table 56. List of specific priority medical devices for intensive care unit interventions for diabetes




Dialysis x X X See 7.1.2. (Table 47) See 7.1.2. (Table 47)

Haemodialysis X X See 7.1.2. (Table 47) See 7.1.2. (Table 47)

Continuous renal replacement therapy

x Continuous renal replacement therapy systemAnaesthesia systema

Set for kidney therapy continues, according to doctor’s prescriptionEffluent collecting bag, 5 litresBicarbonate-based dialysis and replacement solution, bagged Anaesthesia set

Continuous glucose monitoring

X X Blood glucose metera, continuous monitor


Guidance documents

• WHO, Medical devices by health care facility, (https://www.who.int/activities/prioritizing-medical-devices).


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Palliative care


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Rehabilitation is the set of interventions needed when a person is experiencing or is likely to experience

limitations in everyday functioning due to aging or a health condition, including chronic diseases or disorders,

injuries, or traumas. It is an essential component of universal health coverage along with promotion,

prevention, treatment, and palliative care, and it can help to prevent complications associated with many

health conditions, such as spinal cord injury, stroke, or a fracture. Rehabilitation can also help to minimize

or slow down the disabling effects of chronic health conditions, such as cardiovascular disease, cancer, and

diabetes, by equipping people with self-management strategies and the assistive products they require,

or by addressing pain or other complications. There is a broad range of health professionals who provide

rehabilitation interventions, including physiotherapists, occupational therapists, speech and language

therapists, orthotic and prosthetic technicians, and physical medicine and rehabilitation physicians (51).

The type of rehabilitation varies depending on the disease or health complication of each patient. There

is a wide range of innovations and medical devices that can assist a person’s recovery and resumption of

everyday life. Therefore, in this chapter medical devices will not be specified by disease but will be considered

more generally, with usage to be determined by a health professional. Cardiovascular diseases and diabetes

rehabilitation is achieved through medically supervised programs that involve adopting a heart-healthy

lifestyle to address risk factors (52), for example through:

• exercise counseling and training

• education for heart-healthy living

• counseling to reduce stress.

As mentioned above, because rehabilitation interventions are meant to help minimize or slow down the

disabling effects of chronic health conditions, they are not separated by disease but by the rehabilitation

domain. The following tables (Tables 57–68) describe the assistive products, equipment, service delivery

platforms, and health workers needed for each intervention and domain.

Service delivery platforms

For each assessment or intervention, the DG members are asked to confirm the pre-selected service delivery

platforms at which the assessment or intervention should be available. Assessments and interventions can be

assigned to one or more service delivery platforms, depending on where they should be available.

The service delivery platforms are described as follows:

Rehabilitation at First Level Clinical (outpatient health clinics in the community)First level clinics include the first access point for patients with acute health problems or the continuous

delivery of discrete services for patients with chronic conditions. The rehabilitation service is available at a

single-professional practice (e.g. OT practice), or integrated in a general primary health clinic (e.g. GP practice

or primary healthcare centers and clinics). Interventions for rehabilitation are person-centered and are

provided by trained rehabilitation workers or by other health workers either under the supervision of trained

rehabilitation workers or trained in rehabilitation and who may follow rehabilitation protocols (level of care 1).

Rehabilitation at General Referral Clinical (inpatient general hospital, emergency unit)Patients are referred to a general clinic from a first level clinic or admitted through emergency. The rehabilitation

service is integrated in the emergency or acute care (e.g. cardiovascular unit in acute hospital) or general

inpatient service. In such services, multi-professional teams composed of different health professions work

together. Interventions for rehabilitation are person-centered and are provided by trained rehabilitation

workers or by health workers under supervision of trained rehabilitation workers or trained in rehabilitation

and who may follow rehabilitation protocols (level of care 2).

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rehabilitation centers/unit)Patients are referred to a specialized rehabilitation center, or unit from a first level clinic or a general referral

clinic. Such centers or units may be specialized for the care of people with specific health conditions with

complex rehabilitation needs (e.g. spinal cord injury rehabilitation center) or provide rehabilitation for people

with a range of health conditions in a dedicated rehabilitation centre. In such in- or outpatient centers,

multi-disciplinary teams composed of different rehabilitation professions (PRM physician, physiotherapist,

occupational therapist, prosthetist&orthotist, rehabilitation nurse, etc.) work together, these centers and

programmes commonly have capacity for longer-stay and high intensity delivery of rehabilitation interventions.

Interventions for rehabilitation are person-centered and provided by trained rehabilitation workers specialized

for the care of people with specific health conditions or by health workers under supervision of trained

rehabilitation workers or trained in rehabilitation and who may follow rehabilitation protocols (level of care 3).

The list of rehabilitation interventions and assistive products, equipment and consumables required for

general rehabilitation are presented in tables 57 and 58 by level of care: 1st, 2nd or 3rd, as described above.

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Table 57. List of rehabilitation interventions


care

1 2 3General Assessment of cognitive functions X X X

Provision and training in the use of assistive devices for walking X X X

Assessment of exercise capacity X X X

Ischemic heart disease

Screening for sleep apnea X X X

Respiratory muscle strengthening X X

Monitoring of heart rhythm X X

Measurement of blood pressure functions X X X

Resistance training X X X

Assessment of muscle stiffness X X X

Balance training X X X

Physical fitness training (including aerobic exercises, walking, non-weight bearing exercises)

X X X

Assessment of work and employment X X

Assessment of work capacity (treadmill test, 6-min walk test) X X X

Vocational rehabilitation X X

Stress management training (incl. cognitive behavioral training, relaxation therapy)

X X X

Assessment of body composition (body weight) X X X

Diabetes(lower limb amputation)

Epidural treatment X X X

Skin care X X X

Removable Rigid Dressing X X

Assessment of blood vessel functions X X X

Assessment of edema X X X

Compression therapy (incl. Removable Rigid Dressing) X X X

Assessment of joint mobility X X X

Therapeutic interventions (incl. range of motion exercises, stretching) X X X

Assessment of muscle strength X X X

Muscle strengthening X X X

Assessment of gait and walking X X X

Therapeutic interventions (incl. balance training, gait training) X X X

Assessment of mobility X X X

Mobility training (incl. transfer training) X X X

Provision and training in the use of assistive devices for mobility (other than walking)

X X X

Assessment of risk for falls X X

Assessment of driving X X

Driving training X

Assessment of activities of daily living X X X

ADL Training X X X

Provision and training in the use of assistive products incl. environmental modification for ADLs

X X

Physical fitness training X X

Assessment of education, work and employment X X

Educational/Vocational training X X

Environmental modification

Training for recreation and leisure activities (incl. sports) X X

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care

1 2 3Stroke Cognitive training (incl. awareness raising, mnemonic strategies,

errorless learning, cueing)X X X

Physical exercise training X X X

Provision and training in the use of assistive products (incl. environmental modification) for cognition

X X X

Provision and training in the use of assistive products (incl. environmental modification) for perception

X X X


Assessment of visual functions X X X

Eye movement therapy X X X

Provision and training in the use of assistive products for vision X X X

Assessment of mental functions of language X X X

Speech and language therapy (incl. verbal strategies, non-verbal strategies, group conversation therapy)

X X X

Provision and training in the use of assistive products for communication X X X

Assessment of swallowing (incl. videofluoroscopy) X X X

Compensatory and restorative techniques (incl. positioning, biofeedback, nasogastric tube feeding)

X X X

Assessment of body composition (body weight) X X X

Enteral nutrition support X X

Assessment of pain X X X

Intraarticular injections X X X

Therapeutic interventions (incl. range of motion exercises, mirror therapy, positioning, active motor training)

X X X

Provision and training in the use of assistive products for joint protection X X X

Assessment of bowel functions X X X

Assessment of bladder functions X X X

Rectal medications X X X

Therapeutic interventions (incl. muscle strengthening, biofeedback, electrical stimulation, emotional support, diet management)

X X X

Intermittent catheterization X X X

Provision and training in the use of assistive products for incontinence management

X X X

Oral hygiene X X X

Assessment of vascular functions X X X

Heparin injections X X X

Therapeutic interventions (incl. range of motion exercises, retrograde massage, positioning, intermittent pneumatic compression)

X X X

Physical fitness training (incl. walking) X X X

Assessment of joint mobility and stability X X X

Therapeutic interventions (incl. range of motion exercises, antispastic pattern positioning)

X X X

Provision and training in the use of assistive products for joint protection X X X

Therapeutic interventions (incl. electrical stimulation, muscle strengthening, range of motion exercises, antispastic pattern positioning, repetitive task training)

X X X

Botulinum toxin injections X

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care

1 2 3Provision and training in the use of assistive products for joint protection X X

Assessment of balance, control of voluntary movement, gait pattern/walking, hand and arm use

X X X

Therapeutic interventions (incl. biofeedback, electrical stimulation, repetitive task training, treadmill training, aquatic therapy, mirror therapy, constraint induced movement therapy, gait/walking training, escorted walking practice, physical fitness training, virtual reality training, electromechanically assisted training)

X X X

Assessment of driving X

Assessment of activities of daily living X X X

ADL Training (incl. virtual reality training) X X X

Provision and training in the use of assistive products (incl. environmental modification) for ADLs (self-care)

X X X

Assessment of risk for falls X X X

Provision and training in the use of assistive devices (incl. environmental modification) for safe mobility

X X X

Assessment of work and employment X X

Vocational training X X

Work place visits (incl. environmental modification) X X

Leisure therapy X X

10.1 General assistive products for rehabilitation Table 58 presents general assistive products, equipment and consumables required for general rehabilitation.

Table 58. General assistive products, equipment and consumables required for general rehabilitation

General intervention

Level of care

Assistive devices Equipment Consuma-bles

1 2 3Interventions for cognitive functions (intellectual, memory and attention functions)Assessment of cognitive functions (incl. intellectual, memory and attention functions)

X X X • Standardized and Norm-Referenced Tests; Intelligence/cognitive tests or batteries

Provision and training in the use of assistive products for walking

X X X • Early Walking Aids (EWA)• Canes/Sticks• Prostheses, lower limb

Crutches, axillary/elbow• Orthoses (lower limb)

Rollators• Standing frames, adjustable

Walking frames/walkers

• Casting kit• Orthoses kit• Splinting kit (static/

dynamic)• Parallel bars• Prosthetic kit

Tubular

Interventions for exercise and fitness

Assessment of exercise capacity

X X X • Prostheses, lower limb (for limb amputation)

• Automated external defibrillator (AED)

• Blood pressure measurement device

• Cycle ergometer (arm or leg)

• Pedometer• ECG monitor (with or

without telemetry) Parallel bars

• Pulse oximeter• Timer• Tape measure• Treadmill

Electrodes (Replacea-ble sticky)

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diseaseTable 59 presents the specific assistive products, equipment and consumables required for rehabilitation of

people with heart disease.

Table 59. Assistive products, equipment and consumables required for rehabilitation in people with cardiovascular disease (ischemic heart disease)

Intervention Level of care

Assistive devices

Equipment Consumables

1 2 3Interventions for respiration functionsScreening for sleep apnea

X X X • Tape measure

Respiratory muscle strengthening

X X • Resistance bands• Respiratory resistance training

devices

Interventions for cardiovascular and heamatological functionsMonitoring of heart rhythm

X X • ECG monitor (with or without telemetry)

Electrodes (Replaceable sticky)

Measurement of blood pressure functions

X X X • Blood pressure measurement device

Interventions for muscle functions (muscle power functions)Resistance training X X X • Heart rate monitor

• Pulley machine• Resistance bands Weights

Interventions for movement functions (muscle stiffness, involuntary movement reaction functions, gait pattern/walking)Assessment of muscle stiffness

X X X • Goniometer Tape measure

Balance training X X X • Exercise mats

Interventions for exercise and fitnessPhysical fitness training (including aerobic exercises, walking, non-weight bearing exercises)


• Cycle ergometer (arm or leg)• ECG monitor (with or without

telemetry)• Exercise balls

Exercise mats• Heart rate monitor• Pulse oximeter• Resistance bands• Stop watch Treadmill Weights


Interventions for work and employmentAssessment of work and employment

X X • Computer/tablets with software

Assessment of work capacity (treadmill test, 6-min walk test)


• ECG monitor (with or without telemetry)

• Pulse oximeter• Stop watch

Treadmill


Vocational rehabilitation X X • Computer/tablets with software

Interventions for self-management (stress management)Stress management training (incl. cognitive behavioral training, relaxation therapy)

X X X • Exercise mats Pillow

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Interventions for lifestyle modificationAssessment of body composition (body weight)

X X X ScaleTape measure

10.2.2 Specific assistive products for rehabilitation in people with stroke disease

Table 60 presents the specific assistive products, equipment and consumables required for rehabilitation of

people with stroke disease.

Table 60. Assistive products, equipment and consumables required for rehabilitation in people with stroke

InterventionLevel of

care Assistive devices Equipment Consuma-bles

1 2 3Interventions for cognitive functions (intellectual, memory and attention functions)Cognitive training (incl. awareness raising, mnemonic strategies, errorless learning, cueing)

X X X • Communication board/books/cards Communication software (incl. electronic device)

• Calendar• Timer

Physical exercise training

X X X • Body belt (for wheelchair)• Canes/Sticks

Crutches, axillary/elbow Walking frames/walker

• Cycle ergometer (arm or leg) Exercise ball Resistance bands Wall bars

• Parallel bars Pulley machine

• Steps (stackable) Weights

Provision and training in the use of assistive products (incl. environmental modification) for cognition

X X X • Alarm signalers with light/sound/vibration Communication software (incl. electronic device) Orientation board

• Personal emergency alarm systems (PDA) Pill organizers

• Recorders

Interventions for perceptual functions (neglect)Provision and training in the use of assistive products (incl. environmental modification) for perception

X X X • Alarm signalers with light/sound/vibration

• Prism glasses

Interventions for prevention of emotional functions/psychological healthEnvironmental modification

• Lighting control device

Interventions for seeing functionsAssessment of visual functions

X X X • Spectacles; low vision, short distance, long distance, filters and protection

• Color perception charts

• Eye testing booklets• Ophthalmoscope• Snellen chart

Eye movement therapy

X X X • Magnifiers, digital hand-held Spectacles; low vision, short distance, long distance, filters and protection

• Color perception charts Eye patches

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1 2 3Provision and training in the use of assistive products for vision

X X X • Magnifiers, digital hand-held Prism glasses

• Screen readers Spectacles; low vision, short distance, long distance, filters and protection

Interventions for speech, language and communicationAssessment of mental functions of language

X X X • Communication boards/books/cards In-line speaking valves

• Timer

Speech and language therapy (incl. verbal strategies, non-verbal strategies, group conversation therapy)

X X X • Augmentative and alternative communication devices Communication boards/books/cards Communication software (incl. electronic device)

• Keyboard and mouse emulation software Recorders

• Metronome• (Mobile) mirror

Reading materials • Timer

• Gloves Straws Tongue depressor Tissues

Provision and training in the use of assistive products for communication

X X X • Augmentative and alternative communication devices

• Communication boards/books/cards Communication software (incl. electronic device)

Interventions for dysphagia managementAssessment of swallowing (incl. videofluoroscopy)

X X • Camera Flexible laryngoscopy Fluoroscope Laryngoscope Led apron

• Stethoscope Suction Machine

• Videofluoroscopic equipment Wall-mounted x-ray viewer

• X ray machine

• Barium• Food dye

Gloves Modified liquids and solids Oral anes-thetic spray Oral Swabs Straws Tongue depressor

Compensatory and restorative techniques (incl. positioning, biofeedback, nasogastric tube feeding)

X X X • Adapted eating and drinking products

• Biofeedback device Feeding cup Foam rollers Foam wedges

• Pillows Spoon

• Carbonated water

• Food thick-eners Gauze

• Gloves• Hydration/

nutrition bags

• Iced sour suckers

• Lubricant Medical tape

• Modified liquids and solids Nasogastric tubes

• Replaceable sticky elec-trodes

• Straws

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1 2 3Interventions for prevention of malnutritionAssessment of body composition (body weight)

X X X • Fat caliper Scale

• Tape measure

Enteral nutrition support

X X • Feeding machine (pump)• Feeding tubes (in-cluding

PEG tubes)

• Food thickeners Syringes

Interventions for sensation of painAssessment of pain X X X • X-ray machine

Intraarticular injections

X X X • Injection set

Therapeutic interventions (incl. range of motion exercises, mirror therapy, positioning, active motor training)

X X X • Foam rollers Foam wedges

• (Mobile) Mirror Pillow Pulley machine Resistance bands Upper limb workstation Weights

Provision and training in the use of assistive products for joint protection

X X X

Interventions for bowel and bladder managementAssessment of bowel functions

X X • Anorectal physiological studies (CT, MRI, rectosigmoidoscopy exam)

• Stethoscope, Ultrasound

• Wall-mounted x-ray viewer X-ray system

• Gloves Lubricant

Assessment of bladder functions

X X • Bladder Scanner portable• EMG• Fluoroscope

Ultrasound• Urine collection device

(incl. graduated cylinder) specimen cup)

• Urodynamic System Video fluoroscopic equipment Wall-mounted x-ray viewer

• X-ray system

• Catheters Gloves Lubricant

Rectal medications X X X • Suppository inserter • Gloves

Therapeutic interventions (incl. muscle strengthening, biofeedback, electrical stimulation, emotional support, diet management)

X X X • Biofeedback device Exercise ball

• (Functional) electrical stimulation kit

• Gloves• Lubricant

Pads/Diaper• Replaceable

sticky elec-trodes

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1 2 3Intermittent catheterization

X X X • Foam wedges• Mirror

Pillows

• Catheters Gloves Lubricant

Provision and training in the use of assistive products for incontinence management

X X X • Gloves Lubricants

Interventions for the prevention of pneumoniaOral hygiene X X X • Gargle cup

• (Mobile) Mirror• Assisted cough devices

• Oral swabs Mouth wash

• Tissues Tongue depressor

Interventions for prevention of venous thromboembolismAssessment of vascular functions

X X X • Doppler ultrasound• Tape measure

Heparin injections X X X • Injection set

Interventions for edema controlTherapeutic interventions (incl. range of motion exercises, retrograde massage, positioning, intermittent pneumatic compression)

X X X • Foam rollers Foam wedges Intermittent pneumatic compression

• Pillows

• Compression bandages (incl. stump, tubular) Massage lotion

Interventions for exercise and fitnessPhysical fitness training (incl. walking)

X X X • Assistant support belt• Cycle ergometer (arm or

leg) Exercise ball Exercise mats Hoist and sling

• Parallel bars• Pulley machine• Resistance bands

Steps (stackable) Timer

• Training stairs Weights

Interventions for joint functions (mobility and stability)Assessment of joint mobility and stability

X X X • Goniometer• Wall-mounted x-ray

viewer• X-Ray system

Therapeutic interventions (incl. range of motion exercises, antispastic pattern positioning)

X X X • Foam rollers Foam wedges

• Pillows


X X X

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1 2 3Interventions for muscle functions (muscle power and muscle tone functions)Therapeutic interventions (incl. electrical stimulation, muscle strengthening, range of motion exercises, antispastic pattern positioning, repetitive task training)

X X X • Exercise mats• Foam rollers

Foam wedges (Functional) electrical stimulation kit

• Pillow Pulley machine Resistance bands Upper limb workstation

• Weights

• Replaceable sticky elec-trode pads

Botulinum toxin injections

X • Ultrasound scanner • Injection set• Ultrasound

gel


X X • Casting kit Splinting kit (static/dynamic)

• Gauze Gloves

Interventions for movement functions (involuntary movement reaction functions, control of voluntary movement functions, gait pattern/walking, hand and arm use) Assessment of balance, control of voluntary movement, gait pattern/walking, hand and arm use

X X X • Assistant support belt• Balance board

Parallel bars Steps (stackable)

Therapeutic interventions (incl. biofeedback, electrical stimulation, repetitive task training, treadmill training, aquatic therapy, mirror therapy, constraint induced movement therapy, gait/walking training, escorted walking practice, physical fitness training, virtual reality training, electromechanically assisted training)

X X X • Assistant support belt• Balance board• Biofeedback devices

Cycle ergometer (arm or leg)

• Elastic bandages• Electromechanical

devices• Exercise ball

Exercise mats• (Functional) electrical

stimulation kit Harness Hoist and sling Mittens

• Trampoline Metronome (Mobile) Mirror

• Parallel bars Pulley machine

• Resistance bands• Steps (stackable)

Training stairs Treadmill Upper limb workstation Virtual reality equipment

• Water equipment Water floats Wet vests

• Replaceable sticky elec-trode pads

Interventions for drivingAssessment of driving

X • Modified vehicle

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1 2 3Interventions for activities of daily livingAssessment of activities of daily living

X X X

ADL Training (incl. virtual reality training)

X X X • Assistant support belt Stools/Small benches of varying height Virtual reality equipment

Provision and training in the use of assistive products (incl. environmental modification) for ADLs (self-care)

X X X

Interventions for prevention of fallsAssessment of risk for falls

X X X • Balance board Blood pressure measurement device

• Stools/Small benches of varying height Timer

Provision and training in the use of assistive devices (incl. environmental modification) for safe mobility

X X X

Interventions for work and employmentAssessment of work and employment

X X • Computer/tablets with software

Vocational training X X • Calculation workbooks Computer/tablets with software

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1 2 3Work place visits (incl. environmental modification)

X X

Interventions for recreation and leisureLeisure therapy X X • Books

• Crafting supplies Cue (e.g. timer, log, alarm)

• Music• Toys

10.2.3 Specific assistive products for rehabilitation in people with lower limb amputation due to complication of diabetes.

Table 61 presents the specific assistive products, equipment and consumables required for rehabilitation of

people with with lower limb amputation due to diabetes.

Table 61. Assistive devices, equipment and consumables for rehabilitation in people with lower limb amputation due to diabetes

Intervention

Level of care Assistive devices

Equipment

Consuma-bles 1 2 3

Interventions for pain managementEpidural treatment X X Injection set

Interventions for skin and stump careSkin care X X X Alcohol wipes

DressingsGauzeGlovesLubricant

Removable Rigid Dressing

X X Alcohol wipesDressings GlovesPlaster

Interventions for cardiovascular functionsAssessment of blood vessel functions

X X X Doppler ultrasound Plethysmograph

Interventions for edema controlAssessment of edema

X X X Tape measure

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Intervention


Equipment

Consuma-bles 1 2 3

Compression therapy (incl. Removable Rigid Dressing)

X X X Alcohol wipesDressingsElastic and non-elastic bandagesGlovesPlasterPowderStump socks

Interventions for joint functions (mobility of joints)Assessment of joint mobility

X X X Goniometer

Therapeutic interventions (incl. range of motion exercises, stretching)

X X X Exercise mats Foam rollersPillow

Interventions for muscle functions (muscle power functions)Assessment of muscle strength

X X X Resistance bandsWeights

Muscle strengthening

X X X Pulley machineResistance bandsUpper limb workstationWeights

Interventions for movement functions (involuntary movement reaction functions, gait pattern functions/walking)Assessment of gait and walking

X X X Parallel bars

Therapeutic interventions (incl. balance training, gait training)

X X X Balance boardExercise mats(Mobile) mirrorParallel bars Steps (stackable) Training stairs Trampoline

Interventions for MobilityAssessment of mobility

X X X Balance boardExercise matsParallel barsStools/Small benches of varying height Training stairs

Mobility training (incl. transfer training)

X X X Balance boardCycle ergometer (arm or leg)Exercise mats(Mobile) mirrorParallel barsSteps (stackable)Stools/Small benches of varying height Training stairs

Provision and training in the use of assistive devices for mobility (other than walking)

X X X Wheelchair training assistant strap

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Intervention


Equipment

Consuma-bles 1 2 3

Interventions for prevention of falls

Assessment of risk for falls

X X Balance board Foam mat

Interventions for drivingAssessment of driving

X X Modified vehicle

Driving training X Modified vehicle

Interventions for activities of daily livingAssessment of activities of daily living

X X X

ADL Training X X X Stools/Small benches of varying height

Provision and training in the use of assistive products incl. environmental modification for ADLs

X X

Interventions for exercise and fitnessPhysical fitness training

X X Cycle ergometer (arm or leg)Exercise mats Pedometer Stop watch Treadmill

Interventions for education, work and employmentAssessment of education, work and employment

X X Prostheses, lower limb Computer/tablets with software

Educational/Vocational training

X X Computer/tablets with software Basic manual work tools


Hand rail/grab bars Ramps, portable

Interventions for recreation and leisure (including sport)Training for recreation and leisure activities (incl. sports)

X X Canes/Sticks Crutches, axillary/elbowProstheses, lower limb RollatorsWalking frames/walkers

Cycle ergometer (arm or leg) Crafting suppliesTreadmill Toys

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Cardiovascular disease (Ischemic heart disease)The interventions included in these lists have been selected by a development group from the following

clinical practice guidelines:

• National Institute for Health and Care Excellence (NICE): MI - Secondary prevention in primary and

secondary care for patients following a myocardial infarction. Partial update of NICE CG48; 2013

• Scottish Intercollegiate Guidelines Network (SIGN): Cardiac rehabilitation - A national clinical

guideline, SIGN; 2017

• International Council of Cardiovascular Prevention and Rehabilitation’s Consensus statement: Cardiac

rehabilitation delivery model for low-resource settings; 2016

StrokeThe interventions included in these list have been selected by a development group from the following clinical

practice guidelines:

• Scottish Intercollegiate Guidelines Network (SIGN): Management of patients with stroke: Rehabilitation,

prevention and management of complications, and discharge planning; 2010

• National Clinical Guideline Center (NICE): Stroke Rehabilitation - Long term

rehabilitation after stroke; 2013

• Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015

• Australian stroke foundation: Clinical guidelines for stroke management: Chapter 5 (Rehabilitation), 6

(Managing complications) and 8 (Community participation); 2017

Lower limb amputationThe interventions included in these lists have been selected by a development group from the following

clinical practice guidelines:

• Netherlands Society of Physical and Rehabilitation Medicine, ISPO international: Guideline Amputation

due to vascular reasons and prosthetics of the lower limb; 2012

• British Association of Chartered Physiotherapists in Amputee Rehabilitation: Clinical guidelines for the

pre- and post operative physiotherapy management of adults with lower limb amputations; 2016

• Department of Veteran Affairs, Department of Defense: Va/DoD Clinical practice guideline for

rehabilitation of individuals with lower limb amputation; 2017

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11. Palliative care

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PR

IMA

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(C

L, H

C),

S

EC

ON

DA

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(D

H)

AN

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ER

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Le

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*

SE

CO

ND

AR

Y (

DH

)

AN

D T

ER

TIA

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TE

RT

IAR

Y (

SH

)







Clinical laboratory

Clinical assessment





Point of care


General surgery



Intensive care

Hospitaliza-tion

Rehabilitation


Palliative care


care

Rehabilitation

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Palliative care is an approach that improves the quality of life of patients and their families facing the problems

associated with life-threatening illness, through the prevention and relief of suffering by means of early

identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial

and spiritual (53). Palliative care:

• provides relief from pain and other distressing symptoms;

• affirms life and regards dying as a normal process;

• intends neither to hasten nor to postpone death;

• integrates the psychological and spiritual aspects of patient care;

• offers a support system to help patients live as actively as possible until death;

• offers a support system to help the family cope during the patient’s illness and in

their own bereavement;

• uses a team approach to address the needs of patients and their families, including bereavement

counselling, if indicated;

• enhances quality of life, and may also positively influence the course of illness;

• is applicable early in the course of illness, in conjunction with other therapies that are intended to

prolong life, such as chemotherapy or radiation therapy, and includes those investigations needed to

better understand and manage distressing clinical complications.

In some countries, there is recognition of the difference between general palliative care and specialist

palliative care. For example, in the United Kingdom, the National Council for Hospice and Specialist Palliative

Care Services (54) differentiates between:

• general palliative care, which “is provided by the usual professional carers of the patient and family with

low to moderate complexity of palliative care need”; and

• specialist palliative care services, which “are provided for patients and their families with moderate to

high complexity of palliative care need. They are defined in terms of their core service components, their

functions and the composition of the multiprofessional teams that are required to deliver them.”

Terminology in palliative care is somewhat controversial and varies across and even within countries.

Recommended definitions of common terms used in palliative care have been offered by the European

Association for Palliative Care (55, 56) and other organizations. Within a hospital, inpatient specialist

palliative care units (with dedicated beds) can be provided. Alternatively, a multidisciplinary specialist

palliative care team may provide consultations throughout the hospital to patients who remain in their

wards or rooms under the primary care of their treating physician. A hospice may mean a separate service

involving a range of components, including an inpatient unit, home care, day care, outpatient clinics and

bereavement support service.

Detailed recommendations for the type of infrastructure required for palliative care can be found in the WHO

list of priority medical devices for cancer management.

11.1 General priority medical devices for palliative careTables 69 and 70 present general medical devices that can be used for the general palliative care needs of

many diseases, including cardiovascular diseases and diabetes, and specific medical devices.



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Procedure Medical devices category Capital equipment Consumables, single-use

medical devices

Palliative care delivery

Medical equipment Blood glucose metera, portable Micro cuvettes or strips, according to manufacturer

Fixed examination/treatment light

Nebulizer, with accessories

Pulse oximeter, portable, with accessories

Sensors

Refrigerator

Fridge freezer


Thermometer, clinical, digital32–43°C

Sphygmomanometer Cuffs, blood pressure

General physical examination set Includes ophthalmoscope, otoscope, lamp)

Oxygen therapy flowmeter, dial type (if pipeline available)

Oxygen supply (cylinder, oxygen concentrator or pipeline)

Suction availability (accessories for wall or portable equipment)

Electrocardiography systema (optional)

Syringe pump or elastomeric pumps (optional)

Infusion pump for enteral nutrition (optional)

Hammer for neurological examination

Tape measurement

Non-heated respiratory humidifier

Medical furniture Stretcher

General cabinet Infusion set

Dressing trolley, stainless steel, two trays

Lifting device for patient

Wheelchair

Cabinet, medicine, with lock (consider national regulations)

Walking aids

Table, instruments, Mayo type, stainless steel, on castors

Pressure relief mattress

Pressure relief cushion

Instruments Forceps, dressing, Cheron, 250 mm

Surgical instruments, dressing set

Scalpel handle Blades, reusable and single-use

Basic surgery set, minor tray

Personal protective equipment and clothing

Glasses, safety, regular size

Gloves, non-sterile, single-use

Gloves, surgical, single-use


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Table 63. List of general priority medical and assistive devices for pain management, by domain

Domain, intervention category

Assistive products

Capital equipment

Service delivery platform Health worker

Interventions for pain: chronic regional pain syndrome (CRPS), neuropathic pain, shoulder pain

Screening and assessment

Visual analogue scaleX-ray system

First level clinicGeneral referral clinicSpecialized referral clinicOutreach level

General medical practitionerSpecialist medical practitionerPRM physicianNursing professionalOccupational therapistPhysical therapistPsychologistCommunity health worker

Pharmacological agents

First level clinicGeneral referral clinicSpecialized referral clinic Outreach level

General medical practitionerSpecialist medical practitionerPRM physicianNursing professional

Preventive, promotive, restorative and compensatory approaches

Slings Mirror, mobileActivity kit for arm functionPulley machineResistance bandsUpper limb workstationWeightsPillowsFoam rollersFoam wedges


Nursing professionalOccupational therapistPhysical therapistCommunity health worker

Self-management approaches

Slings PillowsFoam wedges


General medical practitionerSpecialist medical practitionerPRM physicianNursing professionalOccupational therapistPhysical therapistCommunity health worker

In addition to all of the above-mentioned medical and assistive devices, it is important to have the following

available in a palliative care setting:

• tools for assessment (approved and validated tools for pain and other symptoms);

• bed sets: sheets, pillows, pillowcases, blankets, duvet, pressure relief mattress, and bed with protective barriers;

• patient’s hygiene tools: soft toothbrush (not pink swabs) for mouth care, hair combs and brushes, manicure and pedicure sets, towels of different sizes and colours, single-use sponges, soap, shampoo, skin cream, incontinence pads, wipes, tissues;

• food provision utensils: dishes, plates, glasses, sipping cups, straws, cutlery, food processors and agents for modifying the consistency of food in cases of dysphagia;

• other furniture and devices: table with light, fan, radio or music device;

• if relatives stay overnight, option to provide a recliner chair or sofa bed;

• aromatherapy.

The palliative care unit should have access to an X-ray system, computed tomography system and echographer,

and blood laboratory test equipment. The devices and furniture should be adapted for adults’ and children’s

needs. Proper patient identification through ID tags or similar is recommended.

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• WHO list of priority medical devices for cancer management (palliative care chapter). Geneva: World Health Organization; 2017 (https://www.who.int/publications/i/item/9789241565462).

• WHO Priority Assistive Products List. Geneva: World Health Organization; 2016 (https://apps.who.int/

iris/bitstream/handle/10665/207694/WHO_EMP_PHI_2016.01_eng.pdf?sequence=1)


https://apps.who.int/iris/bitstream/handle/10665/207694/WHO_EMP_PHI_2016.01_eng.pdf?sequence=1

https://apps.who.int/iris/bitstream/handle/10665/207694/WHO_EMP_PHI_2016.01_eng.pdf?sequence=1

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IV.I Needs assessment for policy and strategy developmentThe lists presented in this document define priority medical devices for clinical interventions extracted

from guidelines addressing selected NCDs: cardiovascular diseases and diabetes. Although the lists are not

exclusive, they can serve as guidance for countries seeking to develop or implement a management policy or

strategy for medical devices specific to these diseases. It is important to note the interdependence of these

technologies: best outcomes cannot be achieved by investing in only one set of technologies. Diagnostic

methods must be combined with therapeutic capability to achieve meaningful impact. This chapter includes

a general implementation strategy and additional considerations to reach pragmatic decisions.

As mentioned, it is important for each country to define an implementation plan that will consider their

country-specific needs, epidemiological situation, availability of infrastructure, and related human resources

and finances, as well as affordability to patients.

The WHO model lists can be used by countries to develop or update their national medical devices list, to support

universal health coverage, address emergencies and ensuring well being of population. Figure 13 illustrates

the general process to adapt the WHO model list to the national situation, perform a needs assessment and

define the medical devices that would be added to the national list. This procedure can be done at regional or

institutional level, as needed. The following section will describe the implementation steps required to increase

access to the specific medical devices selected, to meet the population needs.

Figure 13. General needs assessment process to consider the WHO priority lists to develop or update the national medical devices list.

Source: Modified from WHO needs assessment for medical devices (57).

WHO model lists

National data /specific situation

WHO Priority medical devices lists by level of care and list of clinical practice guidelines

Epidemiological needs/disease prioritiesPopulation data (demography, catchment area, patient rate)

Service availability and accessibilityInfrastructure situation

Health technology/medical device situationHuman resources situation

Affordability to patients, reimbursement scheme

National needs assessment/ consultations

National priority medical

devices list updated

Selection of priority medical devices by national committee

IV. Implementation strategy

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1. Perform a needs assessment of in-country resources for cardiovascular and diabetes management:

a. First, consider the national health plan and any available NCD programme priorities, strategies or objectives:

i. Review country data, epidemiology and registries.

ii. Consider if indicators or evaluation criteria are already in place regarding resources, and specifically medical devices.

b. Define the scope of the implementation plan: national, regional, only specialty hospital or all health facilities, including district hospitals, health centres and community health posts:

i. It is important that all levels of care are included in the considerations of the implementation plan, from community health centres to specialized hospitals, even if only one or many hospitals are being equipped.

ii. The network has to consider reference to higher levels of care, emergency services and outpatient specialized units.

c. Review the lists, unit by unit, with local specialists, and compare to your inventory or availability of technologies to manage NCDs. Note the devices that are general and can serve other diseases.

d. Compile information about resources available or not yet appropriate or sufficient on the following topics:

i. Health facilities that could be used for cardiovascular diseases or diabetes diagnosis or treatment in the scope of the study and related referral services.

ii. Medical devices available per clinical unit, particularly those specified in this document for: » medical imaging » nuclear medicine » laboratory » surgery » palliative care and end-of-life care.

iii. Specialized human resources, particularly those mentioned in this document: » cardiologists, endocrinologists, intensivists, neurologists, specialized nurses » biomedical engineers, equipment technicians » laboratory technicians, biomedical laboratory scientists » medical physicists » radiologists » radiographers.

iv. National treatment guidelines, protocols or care pathways for cardiovascular diseases or diabetes.

v. Priority interventions if defined by an insurance package linked to universal health coverage and reimbursement schemes.

vi. Target population: » types of procedures for types of patients » population distribution in the country » catchment areas for diagnosis » support for patients’ transportation to and stay in treatment centres.

vii. Funding allocation » Depending on the country or setting, this funding could be pre-established or will have to be

calculated depending on the technology required, followed by search for approval. » Funding to support the ongoing interventions for diagnosis, treatment, monitoring and

palliative care is required. » Consider other sponsorships and allocation of funds to national cardiovascular diseases or

diabetes programmes to support patients’ access and affordability.

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2. Once the needs assessment is done and the gaps identified, select an appropriate methodology to prioritize and select which medical devices would be most needed, considering some of the following aspects:

a. Target population.

b. Type of intervention for ccardiovascular diseases or diabetes disease management.

c. Equity, gender and ethical issues, if applicable.

d. Equipment complementary to other diseases.

e. Available budget for:

i. Infrastructure, to install equipment (e.g. haemodialysis units, cardiac cath units, stroke units).

ii. Capital equipment and its life cycle operation, maintenance and consumables.

iii. Procurement and supply of single-use medical devices.

iv. Training of health care workers in safe and appropriate use.

v. Other medical devices, for example in the areas of quality control and safety, complementary to the capital equipment.

f. Feasibility and organizational challenges, such as where to place the technology – where more resources are available or where most of the target population is based.

Most of these considerations are part of health technology assessment and health technology

management studies, subject to a certificate of need. Most of them should be considered by a

specially convened committee to make informed, evidence-based decisions.

3. If a technology is approved for incorporation into the health care system, the following must be considered and defined, usually within a process of health technology management handled by personnel with relevant technical expertise:

a. Regulatory clearance: the regulatory approval process of the specific technology performed by the national regulatory agency – the ministry of health for medical devices, or the nuclear, radiological or similar body for other relevant devices. These entities need to be in continuous collaboration.

b. Technical specifications that are generic and comply with standards to guarantee the technical quality of the device.

c. Bidding process:

i. In the case of haemodialysis, nuclear medicine or other diagnostic and interventional imaging equipment, the mechanical guidelines of the infrastructure are to be considered.

ii. Bids should include extended warranty, training for users, installation and spare parts.

iii. Budget should include operating costs, including maintenance for the whole life cycle of technologies (around 10 years).

d. Government importation requirements.

e. Transportation, insurance, taxes, customs, delivery and installation.

f. Reception of the equipment, verification of installation, and training of the users and health care workers by the manufacturer.

g. Supply chain of consumables.

h. Verification of quality, safety and performance.

i. Decommissioning and waste management procedures (58, 59).

WHO database of priority medical devicesWHO has developed a database, clearing house to host all the medical devices listed in this publication

and other related publications of selection of priority medical devices. “MeDevIS” is the priority medical

devices information systems, webbased, that includes technical information and will be periodically updated.

This can be a very helpful tool to search, review and select medical devices by intervention, by delivery

platform or by publication.

The beta version, as of June 2021, can be found at https://medevis.test.evidenceprime.com.

https://medevis.test.evidenceprime.com

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• WHO list of priority medical devices for cancer management. Geneva: World Health Organization; 2017 (https://www.who.int/publications/i/item/9789241565462).

• Needs assessment for medical devices. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (https://apps.who.int/iris/bitstream/handle/10665/44562/9789241501385-eng.pdf?sequence=1&isAllowed=y).

• Procurement process resource guide. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (http://apps.who.int/iris/bitstream/10665/44563/1/9789241501378_eng.pdf).

• Medical device donations: consideration for solicitation and provision. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (http://apps.who.int/iris/bitstream/10665/44568/1/9789241501408_eng.pdf).

• Introduction to medical equipment inventory management. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (http://apps.who.int/iris/bitstream/10665/44561/1/9789241501392_eng.pdf).

• Medical equipment maintenance programme overview. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (http://apps.who.int/iris/bitstream/10665/44587/1/9789241501538_eng.pdf).

• Computerized maintenance management system. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (http://apps.who.int/iris/bitstream/10665/44567/1/9789241501415_eng.pdf).




http://apps.who.int/iris/bitstream/10665/44563/1/9789241501378_eng.pdf








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The present publication was completed thanks to a collaboration between interdisciplinary experts from

around the world, as well as supportive nongovernmental organizations. It is envisioned that these lists of

medical devices classified by clinical unit will assist policy-makers, health care managers and technical experts

to define the needs of each setting and to inform the development or update of the national medical devices

lists approved for procurement or reimbursement, towards universal health coverage.

Medical devices run the substantial risk of being unused due to technology misalignment with deployment

settings (60). Contextually relevant interventions and devices must be selected to improve resource

allocation in each country, depending on the local needs and resources available. Financing models are

also an important consideration, and their ability to deliver services within health care systems should be

carefully evaluated. The lists presented in this publication should be adapted by a local committee to different

cultural norms and reviewed according to local epidemiology, national policies, regulatory frameworks,

and the available specialized health care workforce, infrastructure, budget, and organizational structures.

It is therefore important to consider innovation, regulatory approval of the technologies, and the health

technology assessment process to enable informed decision-making, taking into consideration equity, social,

clinical and economic aspects as well as health technology management aspects. Such informed decision-

making will ensure that the procurement, installation, training and safe use of technologies is done in the

most effective way, ensuring the well-being of the patient.

The selection of the technologies required from the lists presented in this publication is just the first step of many

to provide best care for patients. These technologies require multidisciplinary expertise to be implemented.

More information will be available from WHO and other agencies to support selection, procurement and best

use of these medical devices for all patients and specifically to target management of NCDs.

Much work is still needed in order to increase access to the appropriate, good-quality medical technology

required to prevent, diagnose, treat, and monitor NCDs worldwide, including cardiovascular diseases and

diabetes, and to develop the human resource competencies of specialized interventions and ensure financial

resources to provide the services under the universal health coverage initiative.

The recent COVID-19 global situation calls for prioritizing investment in prevention and management of health.

It has been noted that population with NCDs are more prone to have COVID-19 complications, therefore the

prevention and management of NCDs is of paramount importance and thus, important to have access to the

medical devices required for them.

V Concluding remarks

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etes All experts provided conflict of interest statements, which were reviewed and assessed in accordance to

WHO requirements and no conflicts were found.

Table A1.1 Experts on cardiovascular diseases and related medical devices

Name Affiliation Country Email Justification

Jitendra Sharma

AMTZ India [email protected] Medical Technologist

Pascal Soroye

Ministry of Health Benin [email protected] Biomedical Engineer

Donald DiPette

University of South Carolina

USA [email protected]

Health Sciences Professor

Keiko Fukuta

Bureau, Ministry of Health, Labour and Welfare

Japan [email protected]

Biomedical Engineer

Ganesan Karthikeyan

Cardiothoracic Sciences Centre, All India Institute of Medical Sciences

India [email protected]

Doctor of Medicine (DM) in Cardiology and Health Sciences Professor

Kamel Abdul Rahim

WHO Iraq Country Office

Iraq [email protected] Technical Officer

Laura Patricia Lopez Meneses

Medical devices consultant

Mexico [email protected] Biomedical engineer and patient perspective

Table A1.2 Experts on stroke and related medical devices


Shrish Naresh Acharya

Colonial War Memorial Hospital

Fiji [email protected]

Consultant Physician

Alexander Kostyuk

Joint Commission for Quality Health Care Services, Ministry of Health

Kazakhstan [email protected]

Chair of HTA Committee

Patrik Michel

World Stroke Organization, CHUV

Switzerland [email protected] Stroke medical specialist

Isabel Watanabe Ortega

Medical Equipment Division, Planning of Medical Infrastructure, IMSS

Mexico [email protected]

Biomedical Engineer

Alessandro Stievano

International Council of Nurses

Switzerland [email protected] Director for Nursing and Health Policy

Annex 1. Expert information

mailto:[email protected]






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Table A1.3 Experts on diabetes and related medical devices


Dinsie Williams Consultant Sierra Leone/Canada

[email protected] Biomedical Engineer

Garry John Norfolk and Norwich University Hospital

United Kingdom

[email protected]

Consultant Clinical Biochemist

Ambady Ramachandran

India Diabetes Research Foundation and Dr. A. Ramachandran’s Diabetes Hospitals

India [email protected]

Medical Doctor

Emma English School of Health Sciences, University of East Anglia

United Kingdom

[email protected]

Clinical Biochemist

Babacar Gueye Ministère de la Santé et de l’Action Sociale

Senegal [email protected] Specialist in Public Health

Santiago Hasdeu

Ministry of Health of Neuquén Province, Comahue National University, participated on behalf of PAHO

Argentina [email protected]

Medical Doctor

Belma Malanda International Diabetes Federation

Belgium [email protected]

Senior Programme Manager

Gabriele Thumann

Hopitaux Universitaires de Geneve

Switzerland [email protected]

Medical Doctor






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Guideline resource Search terms

Emergency Care Research Institute Guidelines Trust

“Essential Hypertension” OR “Coronary Atherosclerosis” OR “Heart Failure” OR “Cardiomyopathy” OR “Valvular Disease” OR “Congenital Heart Disease” OR “Arrhythmia” OR “Arterial Disease” OR “Deep Vein Thrombosis” OR “Pulmonary Embolism” Restricted from 2017 to current

Full database search, select clinical area: Cardiology Restricted from 2017 to current

Turning Research into Practice database

(title: “Essential Hypertension” OR “Coronary Atherosclerosis” OR “Heart Failure” OR “Cardiomyopathy” OR “Valvular Disease” OR “Congenital Heart Disease” OR “Arrhythmia” OR “Arterial Disease” OR “Deep Vein Thrombosis” OR “Pulmonary Embolism”), from 2017

Global Health Library ti:(ti:(“Essential Hypertension” OR “Coronary Atherosclerosis” OR “Heart Failure” OR “Cardiomyopathy” OR “Valvular Disease” OR “Congenital Heart Disease” OR “Arrhythmia” OR “Arterial Disease” OR “Deep Vein Thrombosis” OR “Pulmonary Embolism”) AND (instance:”ghl”) AND (type_of_study:(“guideline”) AND la:(“en”))) AND (instance:”ghl”) AND (year_cluster:(“2016” OR “2017” OR “2018”)) AND (instance:”ghl”)

Guidelines International Network: International Guidelines Library

“Essential Hypertension” OR “Coronary Atherosclerosis” OR “Heart Failure” OR “Cardiomyopathy” OR “Valvular Disease” OR “Congenital Heart Disease” OR “Arrhythmia” OR “Arterial Disease” OR “Deep Vein Thrombosis” OR “Pulmonary Embolism” Restricted from 2017 to current

Canadian Agency for Drugs and Technologies in Health reports

Using filters under “Disease and Conditions” (Acute Coronary Syndrome, Heart Failure, Heart Attack, Peripheral Vascular Disease, Thrombosis), and “Publication date” Restricted from 2017 to current

National Institute for Health and Care Excellence evidence search

“Essential Hypertension” OR “Coronary Atherosclerosis” OR “Heart Failure” OR “Cardiomyopathy” OR “Valvular Disease” OR “Congenital Heart Disease” OR “Arrhythmia” OR “Arterial Disease” OR “Deep Vein Thrombosis” OR “Pulmonary Embolism” Filtered on guidance, area is clinical Restricted from 2017 to current

World Heart Federation

No specific search terms; global search of guidelines

Note: Current = June 2019.

Table A2.2 Search criteria for guidelines on stroke



Full database search, select clinical area: StrokeRestricted from 2017 to current


(title:stroke) from: 2017

Global Health Library ti:(ti:(stroke) AND (instance:”ghl”) AND (type_of_study:(“guideline”) AND la:(“en”))) AND (instance:”ghl”) AND (year_cluster:(“2016” OR “2017” OR “2018”))


“Stroke” Restricted from 2017 to current


Using filters under “Disease and Conditions” (Stroke), and “Publication date” Restricted from 2017 to current


“Stroke” Filtered on guidance, area is clinical Restricted from 2017 to current

World Stroke Organization No specific search terms; global search of guidelines


Annex 2. Search terms for clinical guidelines by Cochrane Netherland

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Table A2.3 Search criteria for guidelines on diabetes



Full database search, select clinical area: Diabetes Restricted from 2017 to current


(title:diabetes) from: 2017

Global Health Library ti:(diabetes) AND (instance:”ghl”) AND (type_of_study:(“guideline”) AND la:(“en”) AND year_cluster:(“2016” OR “2017”))


“Diabetes” Restricted from 2017 to current


Using filters under “Disease and Conditions” (Diabetes), and “Publication date” Restricted from 2017 to current


“Diabetes” Filtered on guidanceRestricted from 2017 to current

International Diabetes Federation

No specific search terms; global search of guidelines


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etes For most items of the NEATS Instrument, there is a 5-point Likert scale from 1 (lowest) to 5 (highest) to score

the degree of adherence to the rating criteria. For the items about transparency and Guideline Development

Group (GDG) composition, there is a scale consisting of “yes”, “no”, or “unknown”. Good quality was defined

as an average score of 3 points or higher (1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent)

combined with clear information on transparency and GDC composition. The Emergency Care Research

Institute Guidelines Trust presents TRUST (Transparency and Rigour Using Standards of Trustworthiness)

scorecards for guidelines. These TRUST scorecards consist of the items of the NEATS instrument. If a TRUST

scorecard was available for a guideline, we used these item scores.

Funding and potential conflicts of interest • The Clinical Practice Guideline (CPG) discloses and states explicitly its funding source.

• Financial conflicts of interest of GDG members have been disclosed and managed.

Composition of the GDG• The GDG includes persons from a variety of relevant clinical specialties and other professional groups.

• The guideline states that it included a methodological expert in the GDG, and it

identifies the methodologist.

Systematic review of evidence • The CPG or a related companion document describes a search strategy that includes a listing of

databases searched; a summary of search terms used; and the specific time period covered by the

literature search, including the beginning date (month and year) and end date (month and year).

• The CPG or a related companion document describes the study selection; description includes

the number of studies identified, the number of studies included, and a summary of inclusion and

exclusion criteria.

• The CPG or a related companion document provides a synthesis of evidence from the selected studies;

i.e., an analysis of individual studies and the body of evidence, in the form of a detailed description or

evidence tables, or both.

Foundations for recommendations • The CPG provides a grading or rating of the level of confidence in or certainty regarding the quality or

strength of the evidence for each recommendation.

• The potential benefits and harms of recommended care are clearly described.

Annex 3. Shortened version of the NEATS instrument (built on the framework of the AGREE II tool)

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s

To synthesize the lists on each section, equipment, medical devices, consumables and disposable devices

are not detailed in the tables. The listed capital equipment is considered complete and ready for operation

when purchased. The accessories are the components external to the main unit (for example, cables, sensors,

probes, trolley), and they are usually delivered with their corresponding capital equipment along with the

internal software, batteries and battery chargers if needed (batteries may be rechargeable or alkaline). Nearly

all medical equipment must be able to function on a power grid as well as on a battery in the event of a failure

of the public electrical grid, for the safety of the patient and to enable completion of the ongoing procedure.

Some accessories or software can vary from child to adult, by age or by gender (for example, blood pressure

cuffs and oximetry sensors). It is advisable to have at least one of each, depending on the patients who will

use the equipment in question.

When a device has several functions, such as the anaesthesia system, it can be integrated into a single system

or kept in separate units.

Table A4.1 Description of select medical devices

Medical device Description and principal components Consumables, single-use

Anaesthesia system A combination of devices that deliver anaesthesia gases and monitor the vital signs of patients who are anaesthetized. The principal components are:ventilator (mechanical or electronic)patient physiological monitor with analysis of anaesthetic gas and CO2, in one or separate units halogen vaporizers, according to the gas usedsoda lime tankoxygen, nitrous oxide, air inlets, which feed a mixer-flowmeter.

Single-use patient breathing circuit for gas (O2, air, N20, halogens)Soda lime

Anaesthesia system, MRI safe

Anaesthesia system that does not contain materials sensitive to the magnetic field of the MRI device.

Needs the same consumables as the ordinary unit

Blood gas analyser, automated or semi-automated

Venipuncture kit

Blood glucose meter A device that measures the amount of sugar (glucose) in blood.a Because it is in direct contact with bodily fluids, disinfection and protection equipment is required when it is in use.

Single-use sterile lancets for capillary blood collectionBlood glucose test strips Disinfectant padsAlcohol and swabsBatteriesGloves

Cardiac catheterization (cath) lab

A suite within a hospital that houses multiple devices that are used for cardiac and vascular interventions, such as coronary angiography and transcatheter aortic valve replacement. The interventions typically involve the insertion of one or more catheters under image guidance. The devices may be used for diagnostic or interventional (treatment) purposes.

CathetersContrast agent

Clinical chemistry analyser

A device that measures the amount of biochemicals in a sample of blood serum, urine, saliva, or tissue, using multiple methods. Interaction of a known chemical or reagent with the sample is used for the assessment. The concentration of the biochemical is compared to a known sample.

ReagentsCalibratorsControlsVenipuncture kit

Annex 4. Explanations concerning medical devices

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Computed tomography (CT) system

A radiographic system that generates transveral images of segments of anatomy. Its primary components are:high-voltage X-ray generatorX-ray tubedetectorelectronic data acquisition systemgantryimage processor.Data from a CT scanner may be transferred to an electronic storage device or an image display system.When the X-ray tube is rotating in the gantry, 4, 16, 32, 64 … slices may be obtained simultaneously per rotation of the tube; 16 slices are enough for imaging nearly all static structures. Cardiac imaging requires at least 32 simultaneous slices. The more simultaneous slices available, the more expensive the equipment, and the more costly its operation and maintenance.

Contrast agent (for select procedures)

Digital storage media An electronic device that can receive, save, and transmit digital data. This can be a compact disc (CD), a digital video disc (DVD), or a memory stick.

CDDVDMemory stick

Dry printer A device that does not use liquids to print. It may be:a thermal printer, which uses thermal papera laser printer, which uses laser filmsa paper printer, which uses standard paper.

Thermal paperLaser filmStandard paper

Electrocardiography system or electrocardiogram (ECG)

A device that measures and displays electrical activity of the heart. It may use 3, 6, 12 data acquisition channels and leads, depending on the procedure.

Electrocardiography electrodes, single-useGel

Emergency cart Medical furniture that contains devices and supplies that are most often needed to treat patients with traumatic conditions:blood pressure device automated external defibrillator (AED) contrast reaction kitemergency kit.

Exercise cardiac stress test device

A device that measures and records a patient’s vital signs as they transition between a state of rest and various active states. It comprises:stress test treadmill or bicycle ergometerelectrocardiography system with 12 leads stress exercise monitoring systempatient physiological monitorautomated external defibrillator (AED)stretcher.

Electrodes Gel

Immunoassay analyser

A device that measures the amount of biochemicals in a sample of blood serum, urine, saliva, or tissue. An antibody’s interaction with the sample is typically evaluated. The concentration of the biochemical is compared to a known sample.

ReagentsCalibratorsControlsVenipuncture kit

Magnetic resonance imaging (MRI) system

A system that produces images of anatomy obtained by analysing radiofrequency signals emitted from tissue under a high-intensity uniform magnetic field. Clinical magnetic field strengths range from 0.5 to 3 Tesla. Systems up to 7 Tesla have been tested on humans. Its primary components are:magnetradiofrequency coils.

Contrast agent

MRI-safe medical device

A device that does not contain materials sensitive to the magnetic field of an MRI system.

Same as the regular device

Patient physiological monitor

A device that displays signals and values reflective of vital signs such as heart rate, blood oxygen saturation, non-invasive blood pressure.

Electrodes Cuffs (various sizes) Oxygen saturation sensors

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Patient breathing circuit

Tubes, connectors and masks that are connected to a ventilator to help a patient breathe. May be reusable or single-use, non-sterile or sterile, for children or adult patients.

Surgery suction system

A device that aspirates fluid from body cavities during surgery. It comprises:electrical or mechanical aspirator of liquid two 5 litre collection vessels antimicrobial filtertubing with a sterile tip or catheter.

Thermometer A device that measures and displays the temperature of a patient. Commonly used thermometers may be analog and contain gallium, or digital with tympanic or infrared technology.

Alcohol swabsProbe coversBatteries (if digital)

Ultrasound scanner A device that uses ultrasonic waves to determine the structure of anatomy. Its primary components are probes, a data acquisition system, and a display. The probes send out sounds waves at frequencies ranging from 3 MHz to about 12 MHz and record echoes from within the body. Low-frequency signals target anatomy far below the surface while high-frequency signals target superficial anatomy and produce images with high spatial resolution. Ultrasound scanners are used commonly for fetal monitoring in obstetrics and in gynaecology. Other applications include functional cardiac and vascular imaging, breast imaging, and abdominal imaging. Probes come in three primary shapes: convex, concave, and linear. Data from an ultrasound scanner may be transferred to an electronic data storage device, a network, a dry printer, or an image display system.

Conductive gelPaper for dry printer Disposable probe drapesAntimicrobial solution to disinfect the probes

X-ray system A radiographic system that produces two-dimensional images of anatomy. The system consists of a high-voltage X-ray generator, an X-ray tube, a flat panel detector, and an image processor (analog or digital).Data from an X-ray system may be transferred to an electronic data storage device, a network, or an image display system.

a. Blood glucose monitoring devices. U.S. Food and Drug Administration (https://www.fda.gov/medical-devices/vitro-diagnostics/blood-glucose-monitoring-devices).

https://www.fda.gov/medical-devices/vitro-diagnostics/blood-glucose-monitoring-devices

https://www.fda.gov/medical-devices/vitro-diagnostics/blood-glucose-monitoring-devices

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Tourniquet

Needles, various sizes


Safety needles

IV catheter

IV saline fluid packages

IV lines

Glass and plastic vials

Vacuum blood collection tubes, with or without anticoagulant

Vacuum container hub and needles

Lancets

Alcohol and swabs or prep swabs

Clean gauze squares

Cotton swabs

Roll of strapping

Gloves, non-latex

Waste container for sharps

Reagent kitDiluent

Distilled water

Reservoir bottle

Cerebrospinal fluid puncture kitSterile universal specimen bottle, grey

Cerebrospinal fluid manometer

Lumbar puncture set, adult and child

Collection tube, sterile plastic tubes


Spinal needle

Spinal anaesthesia needle, single-use


Hypodermic needles: 25G, 23G, 21G

Gauze strip, antimicrobial

Antiseptic skin cleansing agent

Skin marker pen

Urine collection kitUrine collection device (graduated cylinder, specimen cup)

Urine dipsticks

Scale

Sample tubes

Funnel

Annex 5. Instrument kits and sets

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Cath lab setBandbag, 36 x 40 in., with tape 1

Bowl, guidewire, 2500 cc 1

Bowl, sponge,16 oz., 500 cc 1

Clamps, towel

Cover, setup

Domebag

Drape, femoral angiography

Forcep, Halstead mosquito

Gowns

Introducer, guidewire

Labels, waterproof

Marker, skin

Medicine cups, graduated

Needle holder

Needles, 18G x and 25G x

Scalpel handle with blades

Scissors

Sponges


Table cover

Towels

Tray, organizer

Povidone-Iodine Scrub Solutions

Pressure transducer kit

Access sheath(s)

Guidewire, .035 J-tipped, 180/300 cm lengths

Catheters, diagnostic, femoral/radial

Interventional

Catheters, interventional, femoral/radial

Workhorse guidewire(s), 183/300 cm length

Specialty guidewire(s)


Cutting balloon(s)


Bare metal stent(s)

Covered stent(s)

Balloon indeflator

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Bunnell drill set, manual



Protective clamp, with an extreme hole, cross-strips, with zipper, length 150–160 mm

Dandy clamp

Love-Gruenwald clamp, straight, 3 x 10 mm bit, length 180 mm

Kerrison-type clamp







Ferris-Smith clamp, straight, 4 mm bit, length 120 mm

Halsey needle holder, straight, with central slot, with tungsten carbide inserts, length 130–135 mm

Crile-Wood needle holder, straight, stretched jaw, length 145–150 mm


Craniotomy setInstrument tray, stainless steel


Penfield dissector

Handle for bistoury

Backhaus towel clamp, length 130–140 mm

Adson clamp, with 1 x 2 teeth, length 110–125 mm

Foerster or Foerster-Ballenger clamp, straight, crossed, length 180 to 200 mm

Allis clamp, with 4 x 5 teeth, length 150–155 mm

Adson clamp, without teeth, length 110–120 mm

Needle holder

Senn-Mueller separator, round or sharpened point, length 15 cm

Volkmann separator

Farabeuf separator, set of 2, length 150–155 mm

Weitlaner separator, with self-retaining mechanism

Taylor scissors, length 17 cm

Metzenbaum scissors, straight, with tungsten carbide inserts, length 180–185 mm

Mayo scissors, straight, length 150–155 mm

Mayo-Stille scissors, curved, with tungsten carbide inserts, length 145–155 mm

Hudson drill set, 9, 14, 16, 22 mm

McKenzie drill, 13 mm x 9.8 cm

Frazier cannula

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Craniotomy setCobb knife, number

Dandy nerve hook

Sachs hook





Bunnell drill set



Dandy nerve clamp

Ferris-Smith-Kerrison clamp, angle at 40 degrees, 5 mm bit, length 180 mm

Kerrison-type clamp







Crile-Wood needle holder, straight, stretched jaw, with tungsten carbide inserts, length 145–150 mm


Scissors for wire, universal, length 12 cm

Orthopaedic operative setMetal ruler (min 15cm)


Operating scissors

Stitch scissors, standard

Forceps

Bone/cartilage clamp

Rongeur

Bone mallet

Osteotome

Retractor

Suction tube

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Scissors

Forceps, dressing

Forceps, tissue

Needle holder

Forceps, haemostatic

Forceps, towel clamp

Forceps, sponge

Retractor

Forceps, tissue

Dressing setForceps, artery, Kocher, 140 mm, straight



Dishes, kidney type

Reverse osmosis water treatment areaHydropneumatics system





Recirculation pumps


Microfilter

Remote alarm system



Disinfectant


Haemodialysis furnitureHaemodialysis chair with Trendelenburg position

Intravenous pole

Oxygen wall outlet



Sharps container




a This capital medical device is described in the table on generic equipment in Annex 4.

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Haemodialysis setSolutions for haemodialysis: with variable concentrations of calcium and potassium, according to user requirements, sodium bicarbonate for manual or automatic preparation





Reverse osmosis water treatment areaHydropneumatics system





Recirculation pumps


Microfilter

Remote alarm system



Disinfectant


Haemodialysis furnitureHaemodialysis chair with Trendelenburg position

Intravenous pole

Oxygen wall outlet



Sharps container





Haemodialysis setSolutions for haemodialysis: with variable concentrations of calcium and potassium, according to user requirements, sodium bicarbonate for manual or automatic preparation





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Crash cart with automated external defibrillator (AED) and monitoring

Electrocardiography systema

Wheelchair

Electronic scale

Automated, non-invasive blood pressure device



Flexible LED examination lamp on casters

Thermometer

Pulse oximeter

Blood glucose metera, portable

Medication refrigerator

Surgery suction systema, toraxic

Whole blood coagulation analyser

Haematology analyser

Red bag container for hazardous medical waste

Pasteur table, stainless steel

Point-of-care analyser


Ventilator setExpiratory valve assemblies

Flow sensors

Non-invasive ventilation (NIV) mask

Ventilator tubes

Surgery suction system setSuction system tubing (Yankauer suction tube, 270 mm)






EVD setScalpel Handle 3 no, 13.5 cm

Mayo-Stille Surgical Scissors,Curved, 14 cm

Standart Tissue Forcep, 14.5 cm

Foerster-Ballenger Organ and Tissue Forcep, Straight, 24 cm

Allis Tissue Grasping Forcep, 5x6 teeth, 15.5 cm

Backhaus Towel Clamp, 13.5 cm

Halsey Needle Holder, HM, 13 cm

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Micro-Halsted Delicate Haemostatic Forcep, Curved, 12.5 cm

Rochester-Pean Haemostatic Forcep, Curved, 16 cm

Probe, Ø 2.5 mm 14.5 cm

Wire Basket, 255x245x30mm

Endarterectomy set Lemmon disectors, for intimate.

Universal handles for instrumental management.

Flexible handles, of different point, length and gauge.

Long handles to secure the handles.

Specific case for your storage and sterilization.

Lemmon disectors, for intimate.

Universal handles for instrumental management.

Endovascular embolization setIntroducer, guidewire, 18G x 7cm

Guidewire, .035 J-tipped, 180/300cm lengths

Access sheath(s)

Interventional catheters (Femoral / Radial)

.014 Workhorse guidewire(s) 183/300 length

.014 Specialty guidewire (s)


Cutting balloon(s)


Catheter set (filter, needle with luer, case and cap)


Bowl, guidewire, 2500cc 1

Bowl, sponge,16oz., 500cc 1

Embolization material (glue, plastic particles, foeam, metal coil)

Thrombolysis setIntroducer, guidewire, 18G x 7cm


Access sheath(s)





Cutting balloon(s)

Mechanical device to suction or break clot





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Introducer, guidewire, 18G x 7cm


Access sheath(s)





Cutting balloon(s)

Atrial septal occluder





Percutaneous angioplasty setIntroducer, guidewire, 18G x 7cm


Access sheath(s)


Workhorse guidewire(s) 183/300 length

Specialty guidewire (s)


Cutting balloon(s)






WHO medical device technical series

World Health OrganizationMedical Devices Unit20 Avenue Appia1211 GenevaSwitzerland

[email protected]://www.who.int/health-topics/medical-devices

https://www.who.int/health-topics/medical-devices

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